Clinical trial NCT00423670 (phase 2, status: completed)
Conditions: chronic hepatitis c
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: boceprevir (sch 503034), peginterferon-alfa 2b (pegintron), ribavirin, ribavirin (low-dose)
SMILES: [H][C@]12CN([C@H](C(=O)NC(CC3CCC3)C(=O)C(N)=O)[C@@]1([H])C2(C)C)C(=O)[C@@H](NC(=O)NC(C)(C)C)C(C)(C)C, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
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.