Conditions: Hepatitis C, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6661
Healthy volunteers: no

Brief summary:
This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin
Intervention descriptions: intervention 1: 180micrograms sc weekly for 12-48 weeks intervention 2: 800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Protocol document: