We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C (Fibrosar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00265642
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Brief 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

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Irbesartan Drug: placebo Phase 3

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 (ARA2/sartans).

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: group verum
Drug: Irbesartan
Drug: Irbesartan
one tablet of 150 mg/d during 2 years

Placebo Comparator: group placebo Drug: placebo
one tablet per day during 2 years

Primary Outcome Measures :
  1. Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [ Time Frame: at M24 ]

Secondary Outcome Measures :
  1. Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

Layout table for location information
CHU Angers, Service d'hépato-gastroentérologie
Angers, France, 49933 cedex 09
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Layout table for investigator information
Principal Investigator: Paul Cales, MD CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
Study Chair: Fabrice Carrat, MD Inserm U707 France
Additional Information:
Layout table for additonal information
Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT00265642    
Other Study ID Numbers: 2005-006027-37
ANRS HC 19 Fibrosar
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: July 2012
Keywords provided by ANRS, Emerging Infectious Diseases:
Hepatitis C, Chronic
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action