Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C (Fibrosar)
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|ClinicalTrials.gov Identifier: NCT00265642|
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : February 7, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Irbesartan Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||November 2013|
Experimental: group verum
one tablet of 150 mg/d during 2 years
|Placebo Comparator: group placebo||
one tablet per day during 2 years
- Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [ Time Frame: at M24 ]
- Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265642
|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|