Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: boceprevir (SCH 503034); peginterferon-alfa 2b (PegIntron); ribavirin; ribavirin (low-dose)
Intervention description: 200 mg capsules taken as 800 mg orally three times daily (TID); 1.5 μg/kg subcutaneously (SC) once weekly (QW); 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily; 200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 765.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve
      Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2
      parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800
      to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034)
      800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus
      standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG)
      and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000
      mg/day) plus boceprevir for 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 60 years;

          -  Body weight between 45 and 125 kg;

          -  Documented chronic hepatitis C genotype 1;

          -  Liver biopsy with histology consistent with chronic hepatitis and no other etiology
             for chronic liver disease within of 5 years of Day 1;

          -  Participant and participant's partner(s) must each agree to use acceptable methods of
             contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of
             study medication;

          -  Written informed consent.

        Exclusion Criteria:

        Include, but are not limited to, the following:

          -  Prior treatment for hepatitis C;

          -  Co-infection with HIV or hepatitis B virus (HBsAg positive);

          -  Evidence of decompensated liver disease;

          -  Diabetic and hypertensive participants with clinically significant ocular exam
             findings;

          -  Pre-existing psychiatric condition, including but not limited to:

               -  Current moderate or severe depression;

               -  History of depression associated with any of the following:

                    -  Hospitalization for depression;

                    -  Electroconvulsive therapy for depression;

                    -  Depression that resulted in a prolonged absence from work and/or significant
                       disruption of daily functions;

               -  Suicidal or homicidal ideation and/or attempt;

               -  History of severe psychiatric disorders (including but not limited to
                  schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or
                  mania);

               -  Past history or current use of lithium;

               -  Past history or current use of antipsychotic drugs for listed conditions.

          -  Substance abuse within protocol specified timeframes;

          -  Pre-existing medical conditions that could interfere with the participant's
             participation in and completion of the study, including but not limited to chronic
             pulmonary disease, cardiac dysfunction or immunologically-mediated disease;

          -  Active or suspected malignancy or history of malignancy within the past 5 years;

          -  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.

          -  Treatment with any investigational drug or participation in any clinical trial 30 days
             within Screening;

          -  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;

          -  Other clinically significant laboratory test abnormalities.