Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.

Detailed description:

Arms:
arm 1: Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks. arm 2: Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.

Interventions: intervention 1: Ribavirin intervention 2: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 1000/1200mg po bid for 36 or 60 weeks intervention 2: 180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)

Protocol document: