A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Adult patients, 18-65 years of age

• Chronic hepatitis C, genotype 2 or 3

• Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)

• Abdominal sonography within 3 months prior to study start

Exclusion Criteria:

• Previous interferon and/or pegylated interferon and ribavirin therapy

• Liver cirrhosis, class B or C (Child-Pugh)

• Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug

• History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C

• Decompensated liver disease

• Positive for HIV