Fibrosar: Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT00265642

Collaborator

Sanofi (Industry)

166

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Irbesartan Drug: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group verum Drug: Irbesartan	Drug: Irbesartan one tablet of 150 mg/d during 2 years
Placebo Comparator: group placebo	Drug: placebo one tablet per day during 2 years

Arm

Intervention/Treatment

Experimental: group verum

Drug: Irbesartan

Drug: Irbesartan

one tablet of 150 mg/d during 2 years

Placebo Comparator: group placebo

Drug: placebo

one tablet per day during 2 years

Outcome Measures

Primary Outcome Measures

Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [at M24]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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:

hepatocellular carcinoma
HIV
alcool abuser
cirrhosis
anti-fibrotic treatment
pregnancy or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers, Service d'hépato-gastroentérologie	Angers		France	49933 cedex 09

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases
Sanofi

Investigators

Principal Investigator: Paul Cales, MD, CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
Study Chair: Fabrice Carrat, MD, Inserm U707 France