Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b (PEG); Ribavirin (RBV); Placebo; Boceprevir
Intervention description: Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC); Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).; Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID).; Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.
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: 1472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG)
      + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with
      chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active
      anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy
      with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy
      after a 4-week lead-in period may allow for both increased rates of sustained virologic
      response (SVR) and shorter treatment durations (in some populations) than treatment with
      PegIntron plus ribavirin alone.

      The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black
      participants). Participants from each cohort are assigned (randomized) to one of three study
      arms, all of which have a 4-week lead-in period with (PEG + RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have previously documented CHC genotype 1 infection.

          -  Participant must have a liver biopsy with histology consistent with CHC and no other
             etiology.

          -  Participants with bridging fibrosis or cirrhosis 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).

          -  Participant must be >=18 years of age.

          -  Participant must weigh between 40 kg and 125 kg.

          -  Participant and participant's partner(s) must each agree to use acceptable methods of
             contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months
             after last dose of study drug, or longer if dictated by local regulations.

          -  Participants must be willing to give written informed consent.

        Exclusion Criteria:

          -  Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg
             positive).

          -  Participants who received prior treatment for hepatitis C; other than herbal remedies,
             except those with known hepatotoxicity.

          -  Treatment with any investigational drug within 30 days of the randomization visit in
             this study.

          -  Participation in any other clinical trial within 30 days of randomization or intention
             to participate in another clinical trial during participation in this study.

          -  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 participants with clinically significant ocular
             examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal
             hemorrhage, or any other clinically significant abnormality.

          -  Pre-existing psychiatric condition(s).

          -  Clinical diagnosis of substance abuse of the specified drugs within the specified
             timeframes.

          -  Any known pre-existing medical condition that could interfere with the participant's
             participation in and completion of the study.

          -  Evidence of active or suspected malignancy, or a history of malignancy, within the
             last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of
             the skin). Participants under evaluation for malignancy are not eligible.

          -  Participants who are pregnant or nursing. Participants who intend to become pregnant
             during the study period. Male participants with partners who are, or intend to become,
             pregnant during the study period.

          -  Any other condition which, in the opinion of a physician, would make the participant
             unsuitable for enrollment or could interfere with the participant participating in and
             completing the study.

          -  Participants who are part of the site personnel directly involved with this study.

          -  Participants who are family members of the investigational study staff.

          -  Participants who had life-threatening serious adverse event (SAE) during screening
             period.

          -  Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12
             g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3);
             Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN)

          -  Serum albumin < lower limit of normal (LLN)

          -  Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain
             exceptions.

          -  Serum creatinine >ULN of the laboratory reference.

          -  Protocol-specified serum glucose concentrations.

          -  protocol-specified alpha fetoprotein levels.

          -  Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory
             reference range.

          -  Anti-nuclear antibodies (ANA) >1:320.