<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/NCT01710501</url>
  </required_header>
  <id_info>
    <org_study_id>5172-038</org_study_id>
    <secondary_id>2012-003333-42</secondary_id>
    <nct_id>NCT01710501</nct_id>
  </id_info>
  <brief_title>A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)</brief_title>
  <official_title>A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study designed to compare the safety and efficacy of 3 different doses of&#xD;
      grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin&#xD;
      (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC).&#xD;
      Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and&#xD;
      RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of&#xD;
      treatment with Peg-IFN and RBV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2012</start_date>
  <completion_date type="Actual">January 29, 2014</completion_date>
  <primary_completion_date type="Actual">November 25, 2013</primary_completion_date>
  <phase>Phase 2</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>Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)</measure>
    <time_frame>12 weeks after end of treatment (up to 36 weeks total)</time_frame>
    <description>Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</measure>
    <time_frame>14 days following last dose of study drug (up to 26 weeks)</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point</measure>
    <time_frame>From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)</time_frame>
    <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA &lt; 9.3 IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL During Treatment by Time Point</measure>
    <time_frame>From TW 2 through end of treatment (up to 24 weeks)</time_frame>
    <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving SVR4</measure>
    <time_frame>4 weeks after end of treatment (up to 28 weeks total)</time_frame>
    <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Achieving SVR24</measure>
    <time_frame>24 weeks after end of treatment (up to 48 weeks total)</time_frame>
    <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response</measure>
    <time_frame>From Day 1 up to Follow-up Week 24 (up to 48 weeks total)</time_frame>
    <description>Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Chronic Hepatitis C (CHC)</condition>
  <arm_group>
    <arm_group_label>Grazoprevir 25 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a maximum of a 45 day screening window, randomized participants receive 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by Response Guided Therapy (RGT). Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their Hepatitis C virus ribonucleic acid (HCV RNA) level at Treatment Week (TW) 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grazoprevir 50 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a maximum of a 45 day screening window, randomized participants receive 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grazoprevir 100 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a maximum of a 45 day screening window, randomized participants receive 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Grazoprevir</intervention_name>
    <description>Grazoprevir tablet, orally, once per day at assigned dose</description>
    <arm_group_label>Grazoprevir 100 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 25 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 50 mg + PEG-IFN + RBV</arm_group_label>
    <other_name>MK-5172</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>pegylated interferon alfa-2b</intervention_name>
    <description>1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection</description>
    <arm_group_label>Grazoprevir 100 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 25 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 50 mg + PEG-IFN + RBV</arm_group_label>
    <other_name>SCH 054031</other_name>
    <other_name>PegIntron™</other_name>
    <other_name>PEG-IFN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight</description>
    <arm_group_label>Grazoprevir 100 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 25 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 50 mg + PEG-IFN + RBV</arm_group_label>
    <other_name>Rebetol™</other_name>
    <other_name>RBV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match grazoprevir tablets to maintain dose blinding</description>
    <arm_group_label>Grazoprevir 100 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 25 mg + PEG-IFN + RBV</arm_group_label>
    <arm_group_label>Grazoprevir 50 mg + PEG-IFN + RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment naive&#xD;
&#xD;
          -  Chronic, compensated HCV GT1 infection&#xD;
&#xD;
          -  Absence (no medical history or physical findings) of ascites, bleeding esophageal&#xD;
             varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease,&#xD;
             or cirrhosis&#xD;
&#xD;
          -  No evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing&#xD;
             (e.g. FibroScan and/or FibroTest)&#xD;
&#xD;
          -  Must agree to use two acceptable methods of birth control from at least 2 weeks prior&#xD;
             to first dose and continue until at least 6 months after last dose of study drug, or&#xD;
             longer if dictated by local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-GT1 HCV infection, including a mixed GT infection (with a non-GT1) or a&#xD;
             non-typeable genotype.&#xD;
&#xD;
          -  Documented to be Human Immunodeficiency Virus (HIV) positive or co-infected with&#xD;
             hepatitis B virus&#xD;
&#xD;
          -  Hepatocellular carcinoma (HCC) or under evaluation for HCC&#xD;
&#xD;
          -  Participating in or has participated in a study with an investigational compound or&#xD;
             device within 30 days of signing informed consent&#xD;
&#xD;
          -  Diabetic and/or hypertensive with clinically significant ocular examination findings&#xD;
&#xD;
          -  Current or history of central nervous system trauma, seizure disorder, stroke or&#xD;
             transient ischemic attack&#xD;
&#xD;
          -  Chronic pulmonary disease&#xD;
&#xD;
          -  Current or history of any clinically significant cardiac abnormalities/dysfunction&#xD;
&#xD;
          -  Active clinical gout within the last year&#xD;
&#xD;
          -  History of gastric surgery or history of malabsorption disorders&#xD;
&#xD;
          -  Active or suspected malignancy, or a history of malignancy, within the last 5 years&#xD;
             (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)&#xD;
&#xD;
          -  Pregnant, lactating, expecting to conceive or donate eggs, or male participant&#xD;
             planning to impregnate or provide sperm donation or with a female partner who is&#xD;
             pregnant&#xD;
&#xD;
          -  Current moderate or severe depression or history of depression associated with&#xD;
             hospitalization, electroconvulsive therapy, or severe disruption of daily functions,&#xD;
             or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric&#xD;
             disorders&#xD;
&#xD;
          -  Evidence or history of chronic hepatitis not caused by HCV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Canada</country>
    <country>New Zealand</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Lagging M, Brown A, Mantry PS, Ramji A, Weilert F, Vierling JM, Howe A, Gendrano IN 3rd, Hwang P, Zhang B, Wahl J, Robertson M, Mobashery N. Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial. J Viral Hepat. 2016 Feb;23(2):80-8. doi: 10.1111/jvh.12464. Epub 2015 Sep 10.</citation>
    <PMID>26353843</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>February 3, 2016</results_first_submitted>
  <results_first_submitted_qc>February 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 4, 2016</results_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</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>Interferons</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</mesh_term>
    <mesh_term>Peginterferon alfa-2b</mesh_term>
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/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 136 screened participants, 87 were randomized to treatment at 19 sites worldwide.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="P2">
          <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="P3">
          <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="B2">
          <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="B3">
          <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="B4">
          <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="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="87"/>
          </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="52.0" spread="7.9"/>
                    <measurement group_id="B2" value="48.5" spread="12.5"/>
                    <measurement group_id="B3" value="46.4" spread="13.3"/>
                    <measurement group_id="B4" value="48.9" spread="11.6"/>
                  </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="8"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)</title>
        <description>Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.</description>
        <time_frame>12 weeks after end of treatment (up to 36 weeks total)</time_frame>
        <population>Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)</title>
          <description>Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.</description>
          <population>Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</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="24"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2" lower_limit="32.8" upper_limit="74.4"/>
                    <measurement group_id="O2" value="84.0" lower_limit="63.9" upper_limit="95.5"/>
                    <measurement group_id="O3" value="88.5" lower_limit="69.8" upper_limit="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</title>
        <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
        <time_frame>14 days following last dose of study drug (up to 26 weeks)</time_frame>
        <population>All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</title>
          <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
          <population>All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days</title>
        <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>APaT Population; all randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days</title>
          <description>An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.</description>
          <population>APaT Population; all randomized participants who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point</title>
        <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA &lt; 9.3 IU/mL.</description>
        <time_frame>From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)</time_frame>
        <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point</title>
          <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA &lt; 9.3 IU/mL.</description>
          <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</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="29"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 (n=29, 25, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" lower_limit="17.9" upper_limit="54.3"/>
                    <measurement group_id="O2" value="32.0" lower_limit="14.9" upper_limit="53.5"/>
                    <measurement group_id="O3" value="55.2" lower_limit="35.7" upper_limit="73.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=28, 26, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" lower_limit="63.1" upper_limit="93.9"/>
                    <measurement group_id="O2" value="76.9" lower_limit="56.4" upper_limit="91.0"/>
                    <measurement group_id="O3" value="89.7" lower_limit="72.6" upper_limit="97.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=28, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4" lower_limit="81.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="92.3" lower_limit="74.9" upper_limit="99.1"/>
                    <measurement group_id="O3" value="100.0" lower_limit="87.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of All Therapy (n=26, 25, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" lower_limit="74.9" upper_limit="99.1"/>
                    <measurement group_id="O2" value="92.0" lower_limit="74.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="86.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL During Treatment by Time Point</title>
        <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.</description>
        <time_frame>From TW 2 through end of treatment (up to 24 weeks)</time_frame>
        <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL During Treatment by Time Point</title>
          <description>HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.</description>
          <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</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="29"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 (n=29, 25, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" lower_limit="68.3" upper_limit="96.1"/>
                    <measurement group_id="O2" value="88.0" lower_limit="68.8" upper_limit="97.5"/>
                    <measurement group_id="O3" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=28, 26, 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4" lower_limit="81.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.8" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=28, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4" lower_limit="81.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.8" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="87.7" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of all Therapy (n=26, 25, 26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" lower_limit="74.9" upper_limit="99.1"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.3" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="86.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving SVR4</title>
        <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.</description>
        <time_frame>4 weeks after end of treatment (up to 28 weeks total)</time_frame>
        <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving SVR4</title>
          <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.</description>
          <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</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="26"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9" lower_limit="56.4" upper_limit="91.0"/>
                    <measurement group_id="O2" value="88.0" lower_limit="68.8" upper_limit="97.5"/>
                    <measurement group_id="O3" value="92.3" lower_limit="74.9" upper_limit="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Achieving SVR24</title>
        <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.</description>
        <time_frame>24 weeks after end of treatment (up to 48 weeks total)</time_frame>
        <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving SVR24</title>
          <description>HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA &lt;25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.</description>
          <population>Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.</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="24"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2" lower_limit="32.8" upper_limit="74.4"/>
                    <measurement group_id="O2" value="84.0" lower_limit="63.9" upper_limit="95.5"/>
                    <measurement group_id="O3" value="84.6" lower_limit="65.1" upper_limit="95.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response</title>
        <description>Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.</description>
        <time_frame>From Day 1 up to Follow-up Week 24 (up to 48 weeks total)</time_frame>
        <population>Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.</population>
        <group_list>
          <group group_id="O1">
            <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O2">
            <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
          <group group_id="O3">
            <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
            <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response</title>
          <description>Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.</description>
          <population>Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From 1st day of treatment (Day 1) through Follow-up Week 24 (up to 48 weeks)</time_frame>
      <desc>AEs were reported for the APaT Population (all randomized participants who received at least one dose of study treatment) during the treatment period and entire follow-up period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Grazoprevir 25 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="E2">
          <title>Grazoprevir 50 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
        <group group_id="E3">
          <title>Grazoprevir 100 mg + PEG-IFN + RBV</title>
          <description>After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</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="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="28" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="30"/>
              </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="11" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="28"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Monocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="29"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="12" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Aphthous stomatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="29"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="28"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="29"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="28"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="29"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="28"/>
                <counts group_id="E3" events="19" subjects_affected="18" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </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="4" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </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="29"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Red cell distribution width increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="30"/>
              </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="6" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="29"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="28"/>
                <counts group_id="E3" events="17" subjects_affected="13" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</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/NCT01710501
org study id: 5172-038
secondary id: 2012-003333-42
nct id: NCT01710501
lead sponsor: 
has dmc: No
This is a study designed to compare the safety and efficacy of 3 different doses of
      grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin
      (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC).
      Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and
      RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of
      treatment with Peg-IFN and RBV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)
time frame: 12 weeks after end of treatment (up to 36 weeks total)
description: Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.
measure: Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
time frame: 14 days following last dose of study drug (up to 26 weeks)
description: An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.
measure: Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days
time frame: Up to 24 weeks
description: An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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, is also an adverse event.
measure: Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point
time frame: From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)
description: HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.
measure: Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point
time frame: From TW 2 through end of treatment (up to 24 weeks)
description: HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.
measure: Percentage of Participants Achieving SVR4
time frame: 4 weeks after end of treatment (up to 28 weeks total)
description: HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.
measure: Percentage of Subjects Achieving SVR24
time frame: 24 weeks after end of treatment (up to 48 weeks total)
description: HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.
measure: Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response
time frame: From Day 1 up to Follow-up Week 24 (up to 48 weeks total)
description: Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.
arm group label: Grazoprevir 25 mg + PEG-IFN + RBV
arm group type: Experimental
description: After a maximum of a 45 day screening window, randomized participants receive 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by Response Guided Therapy (RGT). Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their Hepatitis C virus ribonucleic acid (HCV RNA) level at Treatment Week (TW) 4.
arm group label: Grazoprevir 50 mg + PEG-IFN + RBV
arm group type: Experimental
description: After a maximum of a 45 day screening window, randomized participants receive 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
arm group label: Grazoprevir 100 mg + PEG-IFN + RBV
arm group type: Experimental
description: After a maximum of a 45 day screening window, randomized participants receive 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
intervention type: Drug
intervention name: Grazoprevir
description: Grazoprevir tablet, orally, once per day at assigned dose
arm group label: Grazoprevir 100 mg + PEG-IFN + RBV
arm group label: Grazoprevir 25 mg + PEG-IFN + RBV
arm group label: Grazoprevir 50 mg + PEG-IFN + RBV
other name: MK-5172
intervention type: Biological
intervention name: pegylated interferon alfa-2b
description: 1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection
arm group label: Grazoprevir 100 mg + PEG-IFN + RBV
arm group label: Grazoprevir 25 mg + PEG-IFN + RBV
arm group label: Grazoprevir 50 mg + PEG-IFN + RBV
other name: SCH 054031
other name: PegIntron™
other name: PEG-IFN
intervention type: Drug
intervention name: Ribavirin
description: Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight
arm group label: Grazoprevir 100 mg + PEG-IFN + RBV
arm group label: Grazoprevir 25 mg + PEG-IFN + RBV
arm group label: Grazoprevir 50 mg + PEG-IFN + RBV
other name: Rebetol™
other name: RBV
intervention type: Drug
intervention name: Placebo
description: Placebo to match grazoprevir tablets to maintain dose blinding
arm group label: Grazoprevir 100 mg + PEG-IFN + RBV
arm group label: Grazoprevir 25 mg + PEG-IFN + RBV
arm group label: Grazoprevir 50 mg + PEG-IFN + RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Canada
country: New Zealand
country: Sweden
country: United Kingdom
country: United States
citation: Lagging M, Brown A, Mantry PS, Ramji A, Weilert F, Vierling JM, Howe A, Gendrano IN 3rd, Hwang P, Zhang B, Wahl J, Robertson M, Mobashery N. Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial. J Viral Hepat. 2016 Feb;23(2):80-8. doi: 10.1111/jvh.12464. Epub 2015 Sep 10.
PMID: 26353843
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: Interferons
mesh term: Ribavirin
mesh term: Interferon-alpha
mesh term: Interferon alpha-2
mesh term: Peginterferon alfa-2b
mesh term: Grazoprevir
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 