Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Boceprevir (BOC); Placebo to boceprevir; Peginterferon alfa-2b (PEG); Ribavirin (RBV); Cross-Over Boceprevir Treatment
Intervention description: 200 mg capsules, 800 mg three times daily by mouth; 200 mg placebo capsules, 800 mg three times daily by mouth; 1.5 mcg/kg/week subcutaneously; 200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily; At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron
      (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared
      to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C
      (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia
      Pacific population. The primary hypothesis is that the proportion of participants achieving
      sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to
      that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously 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

        Exclusion Criteria:

          -  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 prior to
             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.