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.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); ribavirin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official 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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Primary outcome: Treatment completion rateAEs, laboratory parameters.
Secondary outcome: Beck Depression Inventory, HQLQ, SVR, biochemical response.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
SAN FRANCISCO, California 94121, United States
FARMINGTON, Connecticut 06030, United States
HONOLULU, Hawaii 96813, United States
DOWNERS GROVE, Illinois 60515, United States
BALTIMORE, Maryland 21205, United States
NEW YORK, New York 10003, United States
RICHMOND, Virginia 23249, United States
Additional Information
Ending date: October 2006
Last updated: June 17, 2008
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