Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265642

Acronym

Fibrosar

Enrollment

166

Registered

2005-12-15

Start date

2006-10-01

Completion date

2013-11-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic, irbesartan

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.

Interventions

DRUGIrbesartan

one tablet of 150 mg/d during 2 years

DRUGplacebo

one tablet per day during 2 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPaul Cales, MD

CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09

STUDY_CHAIRFabrice Carrat, MD

Inserm U707 France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026