Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin [Copegus]
Intervention descriptions: intervention 1: 180 mcg subcutaneously weekly intervention 2: 1000 mg or 1200 mg orally daily

Protocol document: