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 |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2003 |
| End Date: | October 2006 |
An Open-Label, Multi-Center, Randomized, Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Plus Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.
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.
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.
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
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