A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• 18 years of age

• chronic HCV infection

• HCV genotype 2/3 infection

• active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy

• compensated liver disease

• negative pregnancy test (within 24 hours of first dose of study medication)

• effective contraception for the duration of the study

• written informed consent

Exclusion Criteria:

• previous interferon or ribavirin therapy

• investigation drug use in the 6 weeks prior to first dose of study medication

• infection with HCV genotypes other than 2/3

• HIV infection

• HBV infection

• ongoing severe psychiatric disease

• frequent drug use that is judged by the treating physician to compromise treatment safety

• standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin