Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 948
Healthy volunteers: no

Brief summary:
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Ribavirin intervention 2: Ribavirin intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys] intervention 5: peginterferon alfa-2a [Pegasys] intervention 6: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 1000/1200mg po daily for 72 weeks intervention 2: 1000/1200mg po daily for 48 weeks intervention 3: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks intervention 4: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. intervention 5: 180 micrograms sc weekly for 72 weeks intervention 6: 180 micrograms sc weekly for 48 weeks

Protocol document: