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NCT Number: NCT00265642

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

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

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Angers, Service d'hépato-gastroentérologie

Angers, 49933 cedex 09, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

one tablet of 150 mg/d during 2 years

Placebo

Drug

one tablet per day during 2 years

Primary outcomes

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

    Time frame: at M24

Secondary outcomes

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

    Time frame: at M24

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: Fibrosar

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2005
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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