Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Peginterferon alfa-2b; Ribavirin

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.