Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Phase 3

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: placebo; Drug: Irbesartan

• Registration Number: NCT00265642
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Study Start: 2006-10
• Status Verified: 2012-07
• Primary Completion: 2013-04
• Study Completion: 2013-11
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group placebo	placebo	-
group verum	Irbesartan	Drug: Irbesartan

Primary Outcome Measures

Name	Time	Method
Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24	at M24

Secondary Outcome Measures

Name	Time	Method
Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)	at M24

Trial Locations

Locations (1)

CHU Angers, Service d'hépato-gastroentérologie; 🇫🇷 Angers, France