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.

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

We found this trial at

sites

Clinical Trial Facility in Baltimore Maryland

Baltimore, Maryland

from

Baltimore, MD