Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

This study is currently recruiting participants.

Verified by French National Agency for Research on AIDS and Viral Hepatitis, September 2007

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Sanofi-Synthelabo
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00265642

Purpose

The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adults patients with chronic hepatitis C. The expected total enrollment is 200 patients during two years.

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 hepatic fibrosis and blood markers of hepatic fibrosis

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: Irbesartan	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

Assessment of hepatic fibrosis changes by measurement of area of fibrosis (image analysis method)at M24

Secondary Outcome Measures:

Assessment of hepatic fibrosis changes at M24 by: blood scores of fibrosis, hyaluronate dosage ,prothrombin time and alpha 2 macroglobulinemia dosages

Estimated Enrollment:	200
Study Start Date:	September 2006

Detailed 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 (sartans).

This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age between 18 and 75 years
hepatic biopsy performed (less 12 month before inclusion), fibrosis score F2 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-fibrosis treatment
pregnancy or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265642

Contacts

Contact: Paul Cales, MD	33 2 41 35 34 10	Paul.Cales@ univ-angers.fr
Contact: Frederic Oberti, MD	33 2 41 35 34 08	FrOberti@chu-angers.fr

Locations

France
service de medecine A CHU	Recruiting
Angers, France, 49933
Contact: Emmanuel Quemeneur 33 2 41 35 78 12 EmQuemener@chu-angers.fr
Principal Investigator: Paul Cales, MD

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Sanofi-Synthelabo

Investigators

Principal Investigator:	Paul Cales, MD	service de medecine A CHU Angers France
Study Chair:	Fabrice Carrat, MD	Inserm U 444 France

More Information

Study ID Numbers:	2005-006027-37, ANRS HC 19 Fibrosar
Study First Received:	December 14, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00265642
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Hepatitis C, Chronic
irbesartan

Study placed in the following topic categories:

Liver Diseases
Hepatic fibrosis
Hepatitis, Chronic
Fibrosis
Disease Progression
Irbesartan
Hepatitis, Viral, Human

Angiotensin II
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections

Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009