The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Condition: Chronic Hepatitis C Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Boceprevir; Placebo; peginterferon alfa-2b; Ribavirin
Intervention description: boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO); boceprevir-matched placebo four 200-mg capsules PO TID.; peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC); ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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