Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Irbesartan
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group verum<br>Drug: Irbesartan | Drug: Irbesartan<br>* one tablet of 150 mg/d during 2 years<br>|
| Placebo Comparator: group placebo<br> | Drug: placebo<br>* one tablet per day during 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 |  | at M24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Chronic, irbesartan