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

Phase 2

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00148863
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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 treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

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 for them. Interferon gamma has anti-infectious and anti-fibrosis activity. This study will evaluate the effect, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks, of the addition of interferon gamma in non responders patients. 65 patients will be included in order to include 27 patients who are non responders after 12 weeks of a second treatment and are eligible to receive interferon gamma. Patients will then receive peg-interferon alpha 2a (180 micro g once a week, by injection), ribavirin (1,000 to 1,200 mg per day, according to weight) and interferon gamma (100 micro g thrice a week, by injection) during 8 months

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Status Verified: 2007-08
• Study Completion: 2007-08
• Last Update Submitted: 2007-08-29
• Last Update Posted: 2007-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)

Secondary Outcome Measures

Name	Time	Method
Biochemical response at W72 (ALT below normal value)
Immunologic response (CD4 and CD8 HCV specific)
Virological response at W72
Safety
Quality of life

Trial Locations

Locations (2)

Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie; 🇫🇷 Pessac, France

Hôpital du Haut-Levêque; 🇫🇷 Pessac, France