Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.

The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Sanofi
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

• age between 18 and 75 years

• liver biopsy performed (less 18 month before inclusion), fibrosis score F2,F3 or F3+ in Metavir classification,

• patients without antiviral therapy

• contraindication to anti viral treatment

• non responders or relapsers patients to past antiviral treatment

Exclusion Criteria:

• hepatocellular carcinoma

• HIV

• alcool abuser

• cirrhosis

• anti-fibrotic treatment

• pregnancy or breast feeding