Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Hoffmann-La Roche; InterMune
• Treatments: Interferon alpha-2; Interferon-alpha; Interferon-gamma; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Positive anti-HCV antibodies

• Positive HCV RNA (quantitative method)

• Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months

• Without lower dosage during previous treatment

• Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA

• Metavir over F2 on the most recent biopsy

• ALT increase over normal value twice during last 6 months

Exclusion Criteria:

• HIV infection

• Psychiatric pathology

• Alcool consummation

• Cirrhosis

• Pregnancy or plan of pregnancy

• Breastfeeding