<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/NCT02204475</url>
  </required_header>
  <id_info>
    <org_study_id>5172-066</org_study_id>
    <secondary_id>2014-001841-25</secondary_id>
    <nct_id>NCT02204475</nct_id>
  </id_info>
  <brief_title>Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)</brief_title>
  <official_title>A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 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 randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir&#xD;
      (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and&#xD;
      Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C&#xD;
      virus (HCV)-infected participants. The primary hypothesis is that the proportion of&#xD;
      treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir&#xD;
      + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA])&#xD;
      12 weeks after the end of study therapy (SVR12) will be greater than the proportion of&#xD;
      BOC/PR-treated participants achieving SVR12.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants achieving SVR12</measure>
    <time_frame>Up to Week 60</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of TN participants achieving SVR12</measure>
    <time_frame>Up to Week 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing an adverse event (AE)</measure>
    <time_frame>Up to Week 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants withdrawing from study treatment due to AEs</measure>
    <time_frame>Up to Week 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of PTF participants achieving SVR12</measure>
    <time_frame>Up to Week 60</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>BOC/PR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grazoprevir/Elbasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Grazoprevir/Elbasvir</intervention_name>
    <description>Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).</description>
    <arm_group_label>Grazoprevir/Elbasvir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Boceprevir</intervention_name>
    <description>Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.</description>
    <arm_group_label>BOC/PR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PegIntron</intervention_name>
    <description>Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.</description>
    <arm_group_label>BOC/PR</arm_group_label>
    <other_name>Pegylated Interferon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavarin</intervention_name>
    <description>Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.</description>
    <arm_group_label>BOC/PR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has HCV RNA ≥ 10,000 IU/mL at the time of screening&#xD;
&#xD;
          -  Has documented chronic HCV GT 1 with no evidence of non-typeable or mixed GT infection&#xD;
&#xD;
          -  Is cirrhotic or non-cirrhotic&#xD;
&#xD;
          -  Has HCV treatment status that is treatment naïve, PR null responder; PR partial&#xD;
             responder; or prior PR relapser&#xD;
&#xD;
          -  If human immunodeficiency virus (HIV) co-infected (HIV-1) must be naïve to treatment&#xD;
             with any antiretroviral therapy (ART) and have no plans to initiate ART treatment&#xD;
             while participating in this trial, or be on HIV ART for at least 8 weeks prior to&#xD;
             trial entry (no changes in HIV regimen are allowed within 4 weeks of registration);&#xD;
             must also have at least one viable antiretroviral therapy alternative beyond their&#xD;
             current regimens in the event of HIV virologic failure and the development of&#xD;
             antiretroviral drug resistance&#xD;
&#xD;
          -  Use an acceptable method of contraception or not be of childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has evidence of decompensated liver disease manifested by the presence of or history&#xD;
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other&#xD;
             signs or symptoms of advanced liver disease&#xD;
&#xD;
          -  Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg]&#xD;
             positive)&#xD;
&#xD;
          -  Has a history of malignancy ≤5 years prior to signing informed consent except for&#xD;
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer&#xD;
             or carcinoma in situ; or is under evaluation for other active or suspected malignancy&#xD;
&#xD;
          -  Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of&#xD;
             hepatocellular carcinoma (HCC) or is under evaluation for HCC&#xD;
&#xD;
          -  Has pre-existing psychiatric condition(s)&#xD;
&#xD;
          -  Has clinically-relevant drug or alcohol abuse within 12 months of screening&#xD;
&#xD;
          -  Is a female and is pregnant or breast-feeding, or expecting to become pregnant or&#xD;
             donate eggs from Day 1 throughout treatment and until at least 6 months after the last&#xD;
             dose of study medication, or longer if dictated by local regulations; or is a male&#xD;
             subject and is planning to impregnate or provide sperm donation&#xD;
&#xD;
          -  Has any preexisting condition or prestudy laboratory abnormality, electrocardiogram&#xD;
             (ECG) abnormality or history of any illness, which, in the opinion of the&#xD;
             investigator, might confound the results of the trial or pose additional risk in&#xD;
             administering the study drug(s) to the subject&#xD;
&#xD;
          -  Has a life-threatening severe AE (SAE) during the screening period&#xD;
&#xD;
          -  Has evidence of history of chronic hepatitis not caused by HCV, including but not&#xD;
             limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune&#xD;
             hepatitis&#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>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</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</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Peginterferon alfa-2b</mesh_term>
    <mesh_term>Grazoprevir</mesh_term>
    <mesh_term>Elbasvir-grazoprevir drug combination</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02204475
org study id: 5172-066
secondary id: 2014-001841-25
nct id: NCT02204475
lead sponsor: 
has dmc: No
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir
      (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and
      Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C
      virus (HCV)-infected participants. The primary hypothesis is that the proportion of
      treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir
      + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA])
      12 weeks after the end of study therapy (SVR12) will be greater than the proportion of
      BOC/PR-treated participants achieving SVR12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of participants achieving SVR12
time frame: Up to Week 60
measure: Proportion of TN participants achieving SVR12
time frame: Up to Week 60
measure: Number of participants experiencing an adverse event (AE)
time frame: Up to Week 72
measure: Number of participants withdrawing from study treatment due to AEs
time frame: Up to Week 72
measure: Proportion of PTF participants achieving SVR12
time frame: Up to Week 60
arm group label: BOC/PR
arm group type: Active Comparator
description: All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks.
arm group label: Grazoprevir/Elbasvir
arm group type: Experimental
description: Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks.
intervention type: Drug
intervention name: Grazoprevir/Elbasvir
description: Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).
arm group label: Grazoprevir/Elbasvir
intervention type: Drug
intervention name: Boceprevir
description: Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
arm group label: BOC/PR
intervention type: Drug
intervention name: PegIntron
description: Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
arm group label: BOC/PR
other name: Pegylated Interferon
intervention type: Drug
intervention name: Ribavarin
description: Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.
arm group label: BOC/PR
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
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Interferons
mesh term: Peginterferon alfa-2b
mesh term: Grazoprevir
mesh term: Elbasvir-grazoprevir drug combination