Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
- Conditions
- Health Condition 1: null- CHRONIC HEPATITIS CHealth Condition 2: K739- Chronic hepatitis, unspecified
- Registration Number
- CTRI/2012/04/002540
- Lead Sponsor
- Merck Sharp and Dohme a subsidiary of Merck Co inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 390
Prevoiusly documented CHC genotype 1 infection. Other or mixed genotypes are not eligible
- Liver biopsy with histology consistent with CHC and no other etiology
- Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
- Weight between 40 kg and 125 kg, inclusive
- Of local ancestral descent
- Sexually active males and females of child bearing potential must agree to use a medically accepted method of contraception
- Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
- Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon
- Treatment with RBV within 90 days and any interferon-alpha within 1 month before screening
- Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
- Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
- Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- Diabetes and/or hypertension with clinically significant ocular examination findings
- Any condition the could interfere with participation in and completion of the trial
- Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
- Pregnant or breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virologic response, defined as undetectable plasma hepatitis C <br/ ><br>virus ribonucleic acid (HCV-RNA) at Follow-up Week 24 in participants who <br/ ><br>received at least one dose of any trial medication (i.e. PEG, RBV, BOC, or <br/ ><br>placebo) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: <br/ ><br>No ]Timepoint: Estimated Enrollment: 390 <br/ ><br>Study Start Date: October 2011 <br/ ><br>Estimated Study Completion Date: February 2015 <br/ ><br>Estimated Primary Completion Date: February 2015 (Final data collection <br/ ><br>date for primary outcome measure)
- Secondary Outcome Measures
Name Time Method Sustained virologic response, defined as undetectable plasma HCV-RNA at <br/ ><br>Follow-up Week 24 in participants who received at least one dose of <br/ ><br>experimental trial medication (i.e. placebo or BOC) [ Time Frame: Follow-up <br/ ><br>Week 24 ] [ Designated as safety issue: No ] <br/ ><br>Number of participants achieving early virologic response (undetectable <br/ ><br>HCV-RNA at Treatment Week 8) [ Time Frame: Treatment Week 8 ] [ <br/ ><br>Designated as safety issue: No ]Timepoint: Estimated Enrollment: 390 <br/ ><br>Study Start Date: October 2011 <br/ ><br>Estimated Study Completion Date: February 2015 <br/ ><br>Estimated Primary Completion Date: February 2015 (Final data collection <br/ ><br>date for primary outcome measure)