Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C (Fibrosar)

ANRS, Emerging Infectious Diseases

Status and phase

Completed

Phase 3

Conditions

Hepatitis C, Chronic

Treatments

Drug: placebo

Drug: Irbesartan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00265642

2005-006027-37

ANRS HC 19 Fibrosar

Details and patient eligibility

About

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

Full description

The results of several studies suggests than the AT1 receptor antagonists of angiotensin II have inhibitory effects on TGF-beta 1 production and can limit the progression of liver fibrosis.

Therefore, the angiotensin II could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin II receptors drugs (ARA2/sartans).

This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.

Enrollment

166 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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