Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C (Fibrosar)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C|
- Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [ Time Frame: at M24 ] [ Designated as safety issue: No ]
- Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||November 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: group verum
one tablet of 150 mg/d during 2 years
|Placebo Comparator: group placebo||
one tablet per day during 2 years
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.
|CHU Angers, Service d'hépato-gastroentérologie|
|Angers, France, 49933 cedex 09|
|Principal Investigator:||Paul Cales, MD||CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09|
|Study Chair:||Fabrice Carrat, MD||Inserm U707 France|