Status:
COMPLETED
Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
InterMune
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treatme...
Detailed Description
Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin for 24 Weeks. In many patients, there is no efficacy of this treatment on hepatitis C, and there is no treatment recommended ...
Eligibility Criteria
Inclusion
- 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
- HIV infection
- Psychiatric pathology
- Alcool consummation
- Cirrhosis
- Pregnancy or plan of pregnancy
- Breastfeeding
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00148863
Start Date
June 1 2004
End Date
August 1 2007
Last Update
August 30 2007
Active Locations (2)
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1
Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie
Pessac, France, 33604
2
Hôpital du Haut-Levêque
Pessac, France, 33604