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.

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00087594

Run by

Hoffmann-La Roche

People needed

48

Starts

2003-11-01

Expected to finish

2006-10-01

Last updated by the study team

2016-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — San Francisco, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Downers Grove, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — New York, New York, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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