A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients at least 18 years of age

• CHC infection, genotype 1, 2, or 3

• naive to treatment for CHC infection

• enrolled in a methadone maintenance program with documented attendance for at least 3 months

• use of 2 forms of contraception during the study on both men and women

Exclusion Criteria:

• previous treatment for CHC infection

• co-infection with human immunodeficiency virus (HIV)

• current use of IV or other illicit drugs

• decompensated cirrhosis

• women who are pregnant or breastfeeding