Trial information
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
Protocol number: ML17251
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Open label, multi-center, randomized safety, feasibility and tolerability pilot study of Pegasys® (Peginterferon alfa-2a) Copegus® (Ribavirin) in previous intravenous drug users who are currently enrolled in a methadone maintenance treatment program.
Brief 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.
Target sample size is 48.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Treatment completion rate
Time frame: Week 24/48
2. AEs, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. Beck Depression Inventory, HQLQ, SVR, biochemical response. Time frame: Throughout study
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
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- San Francisco, CA
- Farmington, CT
- Honolulu, HI
- Downers Grove, IL
- Baltimore, MD
- New York, NY
