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.

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087594

ML17251

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Direct Observed Therapy

Experimental group

Description:

Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ribavirin

Self-Administration Therapy

Experimental group

Description:

Participants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ribavirin