<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203149</url>
  </required_header>
  <id_info>
    <org_study_id>5172-058</org_study_id>
    <secondary_id>142638</secondary_id>
    <nct_id>NCT02203149</nct_id>
  </id_info>
  <brief_title>Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)</brief_title>
  <official_title>A Phase II, Randomized Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C and a Phase III, Randomized Placebo-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese&#xD;
      participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding&#xD;
      study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose&#xD;
      determined in Part I in combination with elbasvir. The primary study hypothesis is that the&#xD;
      percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who&#xD;
      achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be&#xD;
      greater than the reference rate of 75%. A separate study arm for cirrhotic participants will&#xD;
      also be included in Part II; these participants will receive grazoprevir at the determined&#xD;
      dose in combination with elbasvir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Part 1, HCV GT1 participants are randomized into one of two arms: 50 mg grazoprevir plus&#xD;
      50 mg elbasvir for 12 weeks during the double blinded (DB) period followed by 24 weeks of&#xD;
      follow-up (FU) during an open-label (OL) period [Arm 1]; or 100 mg grazoprevir plus 50 mg&#xD;
      elbasvir for 12 weeks during the DB followed by 24 weeks of FU during the OL [Arm 2].&#xD;
      Unblinding will occur after all participants complete FU Week 4 at which time the grazoprevir&#xD;
      dose will be selected.&#xD;
&#xD;
      In Part 2, non-cirrhotic HCV GT1 participants and GT1 participants with compensated liver&#xD;
      cirrhosis all receive the selected dose of grazoprevir (50 mg or 100 mg from Part 1) with 50&#xD;
      mg elbasvir for 12 weeks. Non-cirrhotic GT1 participants are randomized to receive either a)&#xD;
      12 weeks of active treatment immediately during the DB with 24 weeks of FU in the OL [Arm&#xD;
      1/Immediate Arm] or b) placebo for 12 weeks with 4 weeks of follow-up during the DB followed&#xD;
      by 12 weeks of active treatment and 24 weeks of follow-up during the OL [Arm 2/Deferred Arm].&#xD;
      All cirrhotic participants [Arm 3/Cirrhotic] receive the selected dose immediately for 12&#xD;
      weeks during the DB with 24 weeks of FU during the OL.&#xD;
&#xD;
      Safety analyses for Part 1 and Part 2 arms will focus on the 12 week treatment phase plus the&#xD;
      first 4 FU weeks. For the Part 2 Deferred Arm this will include the initial 12 week placebo&#xD;
      treatment and first 4 weeks of FU. Efficacy analyses for Parts 1 and 2 will evaluate active&#xD;
      treatment only (Weeks 1-12 for all arms except for Part 2 Deferred Arm which is weeks 16-28).&#xD;
&#xD;
      Part 1:&#xD;
&#xD;
      50 mg grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 1) 100 mg&#xD;
      grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2)&#xD;
&#xD;
      Part 2:&#xD;
&#xD;
      Selected dose of grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm&#xD;
      1/Immediate) Placebo treatment for 12 weeks, 4 weeks follow-up, selected dose of grazoprevir&#xD;
      + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2/Deferred) Selected dose of&#xD;
      grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 3/Cirrhotic)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">May 16, 2016</completion_date>
  <primary_completion_date type="Actual">October 2, 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)</measure>
    <time_frame>12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)</time_frame>
    <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks</measure>
    <time_frame>Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Percentage of Participants That Discontinued Treatment Due to an AE</measure>
    <time_frame>Up to Study Week 12 in Part 1</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks</measure>
    <time_frame>Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE</measure>
    <time_frame>Up to Study Week 12 in Part 2</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time</measure>
    <time_frame>Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
    <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (&lt;LLoQ) Over Time</measure>
    <time_frame>Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24</time_frame>
    <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment</measure>
    <time_frame>Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
    <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Percentage of Participants Achieving HCV RNA &lt;LLoQ Over Time After Active Treatment</measure>
    <time_frame>Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
    <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">399</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Part 1 Grazoprevir 50 mg + Elbasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir by mouth (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Grazoprevir 100 mg + Elbasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2 and are followed-up for 24 weeks during the open-label period of Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Cirrhotic: Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part 1) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Grazoprevir</intervention_name>
    <description>One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.</description>
    <arm_group_label>Part 1 Grazoprevir 100 mg + Elbasvir</arm_group_label>
    <arm_group_label>Part 1 Grazoprevir 50 mg + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Cirrhotic: Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elbasvir</intervention_name>
    <description>One 50 mg tablet taken orally once daily for 12 weeks.</description>
    <arm_group_label>Part 1 Grazoprevir 100 mg + Elbasvir</arm_group_label>
    <arm_group_label>Part 1 Grazoprevir 50 mg + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Cirrhotic: Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Grazoprevir</intervention_name>
    <description>One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.</description>
    <arm_group_label>Part 1 Grazoprevir 50 mg + Elbasvir</arm_group_label>
    <arm_group_label>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Elbasvir</intervention_name>
    <description>One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.</description>
    <arm_group_label>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has documented chronic Japanese HCV genotype (GT) 1 with no evidence of non-typeable&#xD;
             or mixed GT infection&#xD;
&#xD;
          -  Is treatment-naïve, or intolerant or non-responder to prior anti-HCV interferon&#xD;
             (IFN)-based treatment without direct acting antiviral (DAA) therapy, prior IFN-based&#xD;
             treatment with DAA therapy, or prior DAA therapy&#xD;
&#xD;
          -  Agrees to the use of contraception if a female of reproductive potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has evidence of decompensated liver disease manifested by the presence of or history&#xD;
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other&#xD;
             signs or symptoms of advanced liver disease&#xD;
&#xD;
          -  Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Has a history of malignancy ≤5 years prior to signing informed consent except for&#xD;
             adequately treated basal cell or squamous cell skin cancer or carcinoma in situ&#xD;
&#xD;
          -  Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of&#xD;
             hepatocellular carcinoma (HCC) or is under evaluation for HCC (Part 2 only)&#xD;
&#xD;
          -  Has clinically-relevant drug or alcohol abuse within 12 months of screening&#xD;
&#xD;
          -  Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs&#xD;
             from Day 1 and continue throughout treatment and follow-up (or longer if dictated by&#xD;
             local regulations)&#xD;
&#xD;
          -  Has any of the following conditions:&#xD;
&#xD;
          -  Organ transplants (including hematopoietic stem cell transplants) other than cornea&#xD;
             and hair&#xD;
&#xD;
          -  Poor venous access&#xD;
&#xD;
          -  History of gastric surgery (e.g., stapling, bypass) or subject with a history of&#xD;
             malabsorption disorders (e.g., celiac sprue disease)&#xD;
&#xD;
          -  History of a medical/surgical condition that resulted in hospitalization within the 3&#xD;
             months prior to enrollment, other than for minor elective procedures&#xD;
&#xD;
          -  Medical/surgical conditions that may result in a need for hospitalization during the&#xD;
             period of the study&#xD;
&#xD;
          -  Any medical condition requiring, or likely to require, chronic systemic administration&#xD;
             of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the&#xD;
             course of the trial&#xD;
&#xD;
          -  Has chronic hepatitis not caused by HCV, including but not limited to nonalcoholic&#xD;
             steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Japan</country>
  </removed_countries>
  <results_reference>
    <citation>Kumada H, Suzuki Y, Karino Y, Chayama K, Kawada N, Okanoue T, Itoh Y, Mochida S, Toyoda H, Yoshiji H, Takaki S, Yatsuzuka N, Yodoya E, Iwasa T, Fujimoto G, Robertson MN, Black S, Caro L, Wahl J. The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study. J Gastroenterol. 2017 Apr;52(4):520-533. doi: 10.1007/s00535-016-1285-y. Epub 2016 Nov 21.</citation>
    <PMID>27873094</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>August 18, 2016</results_first_submitted>
  <results_first_submitted_qc>August 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 11, 2016</results_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 432 screened, 63 were enrolled and randomized to Part 1 and 336 were enrolled and randomized to Part 2, for a total of 399 randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="P2">
          <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="P3">
          <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="P4">
          <title>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</title>
          <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="P5">
          <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
          <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants of Part 1 did not enter Part 2</participants>
                <participants group_id="P2" count="0">Participants of Part 1 did not enter Part 2</participants>
                <participants group_id="P3" count="227"/>
                <participants group_id="P4" count="74"/>
                <participants group_id="P5" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started Deferred Active Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="73">1 participant in Deferred Treatment Arm receiving Placebo did not receive Deferred Active Treatment.</participants>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="226"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="B2">
          <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="B3">
          <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="B4">
          <title>Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir</title>
          <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="B5">
          <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
          <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="227"/>
            <count group_id="B4" value="74"/>
            <count group_id="B5" value="35"/>
            <count group_id="B6" value="399"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="9.7"/>
                    <measurement group_id="B2" value="58.0" spread="12.5"/>
                    <measurement group_id="B3" value="61.1" spread="12.5"/>
                    <measurement group_id="B4" value="60.9" spread="10.8"/>
                    <measurement group_id="B5" value="64.8" spread="9.2"/>
                    <measurement group_id="B6" value="61.1" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="140"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)</title>
        <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.</description>
        <time_frame>12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)</time_frame>
        <population>The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
            <description>Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
          <group group_id="O4">
            <title>Part 2 Non-cirrhotic Deferred: Placebo</title>
            <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
            <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)</title>
          <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.</description>
          <population>The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="96.6" lower_limit="92.3" upper_limit="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).</description>
        <time_frame>Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)</time_frame>
        <population>All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).</description>
          <population>All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7"/>
                    <measurement group_id="O2" value="74.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Percentage of Participants That Discontinued Treatment Due to an AE</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.</description>
        <time_frame>Up to Study Week 12 in Part 1</time_frame>
        <population>All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants That Discontinued Treatment Due to an AE</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.</description>
          <population>All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time</title>
        <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
        <time_frame>Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
        <population>All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time</title>
          <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
          <population>All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TW2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" lower_limit="9.6" upper_limit="41.1"/>
                    <measurement group_id="O2" value="35.5" lower_limit="19.2" upper_limit="54.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                    <measurement group_id="O2" value="83.9" lower_limit="66.3" upper_limit="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O2" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (&lt;LLoQ) Over Time</title>
        <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
        <time_frame>Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24</time_frame>
        <population>All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (&lt;LLoQ) Over Time</title>
          <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
          <population>All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TW2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3" lower_limit="42.2" upper_limit="78.2"/>
                    <measurement group_id="O2" value="71.0" lower_limit="52.0" upper_limit="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
        <time_frame>Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)</time_frame>
        <population>All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Non-cirrhotic Deferred: Placebo</title>
            <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
            <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
          <population>All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.8"/>
                    <measurement group_id="O2" value="67.6"/>
                    <measurement group_id="O3" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.5</ci_lower_limit>
            <ci_upper_limit>10.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
        <time_frame>Up to Study Week 12 in Part 2</time_frame>
        <population>All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Non-cirrhotic Deferred: Placebo</title>
            <description>Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
            <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.</description>
          <population>All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="1.4"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment</title>
        <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
        <time_frame>Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
        <population>All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir</title>
            <description>During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
            <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment</title>
          <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
          <population>All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TW2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="19.6" upper_limit="31.3"/>
                    <measurement group_id="O2" value="39.7" lower_limit="28.5" upper_limit="51.9"/>
                    <measurement group_id="O3" value="11.4" lower_limit="3.2" upper_limit="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5" lower_limit="64.1" upper_limit="76.3"/>
                    <measurement group_id="O2" value="86.3" lower_limit="76.2" upper_limit="93.2"/>
                    <measurement group_id="O3" value="65.7" lower_limit="47.8" upper_limit="80.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" lower_limit="94.9" upper_limit="99.3"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="96.2" upper_limit="99.7"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="95.5" upper_limit="99.5"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="97.1" lower_limit="85.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.2" upper_limit="98.5"/>
                    <measurement group_id="O2" value="95.9" lower_limit="88.5" upper_limit="99.1"/>
                    <measurement group_id="O3" value="97.1" lower_limit="85.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.2" upper_limit="98.5"/>
                    <measurement group_id="O2" value="95.9" lower_limit="88.5" upper_limit="99.1"/>
                    <measurement group_id="O3" value="94.3" lower_limit="80.8" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Percentage of Participants Achieving HCV RNA &lt;LLoQ Over Time After Active Treatment</title>
        <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
        <time_frame>Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24</time_frame>
        <population>All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
            <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir</title>
            <description>During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
            <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percentage of Participants Achieving HCV RNA &lt;LLoQ Over Time After Active Treatment</title>
          <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA &lt;LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.</description>
          <population>All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TW2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8" lower_limit="54.1" upper_limit="67.2"/>
                    <measurement group_id="O2" value="69.9" lower_limit="58.0" upper_limit="80.1"/>
                    <measurement group_id="O3" value="60.0" lower_limit="42.1" upper_limit="76.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="92.6" upper_limit="98.2"/>
                    <measurement group_id="O2" value="98.6" lower_limit="92.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="94.3" lower_limit="80.8" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TW12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="96.2" upper_limit="99.7"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="95.5" upper_limit="99.5"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="97.1" lower_limit="85.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.2" upper_limit="98.5"/>
                    <measurement group_id="O2" value="97.3" lower_limit="90.5" upper_limit="99.7"/>
                    <measurement group_id="O3" value="97.1" lower_limit="85.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FUWK24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.2" upper_limit="98.5"/>
                    <measurement group_id="O2" value="95.9" lower_limit="88.5" upper_limit="99.1"/>
                    <measurement group_id="O3" value="97.1" lower_limit="85.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks</time_frame>
      <desc>All randomized participants who received ≥1 dose of study treatment and had any safety follow-up data. AEs were reported by the treatment that participants were receiving at the time of the event; AEs for Deferred Arm reported separately for placebo and active treatment. Part 1 database=MedDRA 18.1, Part 2 database=MedDRA 19.0</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1 Grazoprevir 50 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="E2">
          <title>Part 1 Grazoprevir 100 mg + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.</description>
        </group>
        <group group_id="E3">
          <title>Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir</title>
          <description>Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
        <group group_id="E4">
          <title>Part 2 Non-cirrhotic Deferred: Placebo</title>
          <description>Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.</description>
        </group>
        <group group_id="E5">
          <title>Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir</title>
          <description>During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.</description>
        </group>
        <group group_id="E6">
          <title>Part 2 Cirrhotic: Grazoprevir + Elbasvir</title>
          <description>Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1 &amp; 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Cardiac sarcoidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Haemorrhagic erosive gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lead dislodgement</sub_title>
                <description>appears under &quot;Product Issues&quot; in MedDRA v. 19.0</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Benign anorectal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Gastrointestinal tract adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1 &amp; 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="109" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="74"/>
                <counts group_id="E5" subjects_affected="42" subjects_at_risk="73"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="227"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="31"/>
                <counts group_id="E3" events="56" subjects_affected="47" subjects_at_risk="227"/>
                <counts group_id="E4" events="18" subjects_affected="12" subjects_at_risk="74"/>
                <counts group_id="E5" events="25" subjects_affected="20" subjects_at_risk="73"/>
                <counts group_id="E6" events="11" subjects_affected="8" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="227"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" events="13" subjects_affected="11" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="227"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator or sub-investigators may publicly present the academic accomplishment acquired from the Study at a specialized academic meeting or research conference. The Sponsor may freely use the information acquired from the Study for the purpose of marketing authorization application of the test drug.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203149
org study id: 5172-058
secondary id: 142638
nct id: NCT02203149
lead sponsor: 
has dmc: Yes
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese
      participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding
      study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose
      determined in Part I in combination with elbasvir. The primary study hypothesis is that the
      percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who
      achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be
      greater than the reference rate of 75%. A separate study arm for cirrhotic participants will
      also be included in Part II; these participants will receive grazoprevir at the determined
      dose in combination with elbasvir.
In Part 1, HCV GT1 participants are randomized into one of two arms: 50 mg grazoprevir plus
      50 mg elbasvir for 12 weeks during the double blinded (DB) period followed by 24 weeks of
      follow-up (FU) during an open-label (OL) period [Arm 1]; or 100 mg grazoprevir plus 50 mg
      elbasvir for 12 weeks during the DB followed by 24 weeks of FU during the OL [Arm 2].
      Unblinding will occur after all participants complete FU Week 4 at which time the grazoprevir
      dose will be selected.

      In Part 2, non-cirrhotic HCV GT1 participants and GT1 participants with compensated liver
      cirrhosis all receive the selected dose of grazoprevir (50 mg or 100 mg from Part 1) with 50
      mg elbasvir for 12 weeks. Non-cirrhotic GT1 participants are randomized to receive either a)
      12 weeks of active treatment immediately during the DB with 24 weeks of FU in the OL [Arm
      1/Immediate Arm] or b) placebo for 12 weeks with 4 weeks of follow-up during the DB followed
      by 12 weeks of active treatment and 24 weeks of follow-up during the OL [Arm 2/Deferred Arm].
      All cirrhotic participants [Arm 3/Cirrhotic] receive the selected dose immediately for 12
      weeks during the DB with 24 weeks of FU during the OL.

      Safety analyses for Part 1 and Part 2 arms will focus on the 12 week treatment phase plus the
      first 4 FU weeks. For the Part 2 Deferred Arm this will include the initial 12 week placebo
      treatment and first 4 weeks of FU. Efficacy analyses for Parts 1 and 2 will evaluate active
      treatment only (Weeks 1-12 for all arms except for Part 2 Deferred Arm which is weeks 16-28).

      Part 1:

      50 mg grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 1) 100 mg
      grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2)

      Part 2:

      Selected dose of grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm
      1/Immediate) Placebo treatment for 12 weeks, 4 weeks follow-up, selected dose of grazoprevir
      + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 2/Deferred) Selected dose of
      grazoprevir + 50 mg elbasvir treatment for 12 weeks, 24 weeks follow-up (Arm 3/Cirrhotic)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)
time frame: 12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)
description: Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.
measure: Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks
time frame: Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).
measure: Part 1: Percentage of Participants That Discontinued Treatment Due to an AE
time frame: Up to Study Week 12 in Part 1
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.
measure: Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks
time frame: Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
measure: Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE
time frame: Up to Study Week 12 in Part 2
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.
measure: Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time
time frame: Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
measure: Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time
time frame: Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24
description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
measure: Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment
time frame: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
measure: Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment
time frame: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.
arm group label: Part 1 Grazoprevir 50 mg + Elbasvir
arm group type: Experimental
description: Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir by mouth (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
arm group label: Part 1 Grazoprevir 100 mg + Elbasvir
arm group type: Experimental
description: Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
arm group label: Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
arm group type: Experimental
description: Non-cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2 and are followed-up for 24 weeks during the open-label period of Part 2.
arm group label: Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
arm group type: Placebo Comparator
description: Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take grazoprevir (50 mg or 100 mg dose selected from Part I) and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
arm group label: Part 2 Cirrhotic: Grazoprevir + Elbasvir
arm group type: Experimental
description: Cirrhotic participants take grazoprevir (50 mg or 100 mg dose selected from Part 1) and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
intervention type: Drug
intervention name: Grazoprevir
description: One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.
arm group label: Part 1 Grazoprevir 100 mg + Elbasvir
arm group label: Part 1 Grazoprevir 50 mg + Elbasvir
arm group label: Part 2 Cirrhotic: Grazoprevir + Elbasvir
arm group label: Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
arm group label: Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
intervention type: Drug
intervention name: Elbasvir
description: One 50 mg tablet taken orally once daily for 12 weeks.
arm group label: Part 1 Grazoprevir 100 mg + Elbasvir
arm group label: Part 1 Grazoprevir 50 mg + Elbasvir
arm group label: Part 2 Cirrhotic: Grazoprevir + Elbasvir
arm group label: Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
arm group label: Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir
intervention type: Drug
intervention name: Placebo to Grazoprevir
description: One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.
arm group label: Part 1 Grazoprevir 50 mg + Elbasvir
arm group label: Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
intervention type: Drug
intervention name: Placebo to Elbasvir
description: One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.
arm group label: Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Japan
citation: Kumada H, Suzuki Y, Karino Y, Chayama K, Kawada N, Okanoue T, Itoh Y, Mochida S, Toyoda H, Yoshiji H, Takaki S, Yatsuzuka N, Yodoya E, Iwasa T, Fujimoto G, Robertson MN, Black S, Caro L, Wahl J. The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study. J Gastroenterol. 2017 Apr;52(4):520-533. doi: 10.1007/s00535-016-1285-y. Epub 2016 Nov 21.
PMID: 27873094
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Grazoprevir
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 