Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

— Fibrosar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265642
• Other study ID #: 2005-006027-37
• Secondary ID: ANRS HC 19 Fibro
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2005
• Last updated: February 6, 2014
• Start date: October 2006
• Est. completion date: November 2013

Study information

• Verified date: July 2012
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Irbesartan
one tablet of 150 mg/d during 2 years
• placebo
one tablet per day during 2 years

Locations

Country	Name	City	State
France	CHU Angers, Service d'hépato-gastroentérologie	Angers

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24		at M24	No
Secondary	Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)		at M24	No

External Links

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