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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
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a [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

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 PegasysŪ (Peginterferon Alfa-2a) CopegusŪ (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Treatment completion rate\n

AEs, 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

Starting date: November 2003
Last updated: August 17, 2015

Page last updated: August 23, 2015

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