Status:
COMPLETED
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.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 prog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00087594
Start Date
November 1 2003
End Date
October 1 2006
Last Update
March 4 2016
Active Locations (7)
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1
San Francisco, California, United States, 94121
2
Farmington, Connecticut, United States, 06030
3
Honolulu, Hawaii, United States, 96813
4
Downers Grove, Illinois, United States, 60515