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The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Primary Purpose

Chronic Hepatitis C Genotype 1

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Boceprevir
Placebo
peginterferon alfa-2b
Ribavirin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Genotype 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • body weight ≥40 kg and ≤125 kg
  • previously documented CHC genotype 1 infection;
  • must have a liver biopsy with histology consistent with CHC and no other etiology
  • if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
  • agree to use acceptable methods of contraception with partner
  • previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV

Exclusion criteria:

  • co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).
  • required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
  • treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
  • treatment with any investigational drug within 30 days of the screening visit in this trial
  • evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • diabetic and/or hypertensive with clinically significant ocular examination findings
  • clinical diagnosis of substance abuse of specified drugs within specified timeframes
  • any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    RGT BOC + PR

    PBO + PR (Control)

    Crossover Arm

    Arm Description

    Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.

    Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.

    Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
    SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

    Secondary Outcome Measures

    Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
    SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
    Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
    EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.

    Full Information

    First Posted
    August 26, 2011
    Last Updated
    January 15, 2021
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01425203
    Brief Title
    The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
    Official Title
    Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 23, 2011 (Actual)
    Primary Completion Date
    October 21, 2013 (Actual)
    Study Completion Date
    October 21, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Genotype 1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    238 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RGT BOC + PR
    Arm Type
    Experimental
    Arm Description
    Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
    Arm Title
    PBO + PR (Control)
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
    Arm Title
    Crossover Arm
    Arm Type
    Experimental
    Arm Description
    Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.
    Intervention Type
    Drug
    Intervention Name(s)
    Boceprevir
    Other Intervention Name(s)
    SCH 503034
    Intervention Description
    boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    boceprevir-matched placebo four 200-mg capsules PO TID.
    Intervention Type
    Biological
    Intervention Name(s)
    peginterferon alfa-2b
    Other Intervention Name(s)
    PegIntron
    Intervention Description
    peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Description
    ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
    Description
    SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
    Time Frame
    Follow-up Week 24 (up to 72 weeks)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
    Description
    SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
    Time Frame
    Follow-up Week 24 (up to 72 weeks)
    Title
    Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
    Description
    EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.
    Time Frame
    Treatment Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: body weight ≥40 kg and ≤125 kg previously documented CHC genotype 1 infection; must have a liver biopsy with histology consistent with CHC and no other etiology if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC) agree to use acceptable methods of contraception with partner previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV Exclusion criteria: co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive). required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related) treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening treatment with any investigational drug within 30 days of the screening visit in this trial evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy diabetic and/or hypertensive with clinically significant ocular examination findings clinical diagnosis of substance abuse of specified drugs within specified timeframes any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    26962399
    Citation
    Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=P08160&kw=P08160&tab=access

    Learn more about this trial

    The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

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