Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 896
Healthy volunteers: no

Brief summary:
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Detailed description:

Arms:
arm 1: Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment. arm 2: Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.

Interventions: intervention 1: PEG-IFN alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms. intervention 2: Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.

Protocol document: