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

February 6, 2014 updated by: ANRS, Emerging Infectious Diseases

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933 cedex 09
        • CHU Angers, Service d'hépato-gastroentérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Sanofi

Investigators

  • Principal Investigator: Paul Cales, MD, CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
  • Study Chair: Fabrice Carrat, MD, Inserm U707 France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-006027-37
  • ANRS HC 19 Fibrosar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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