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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Irbesartan

placebo

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, irbesartan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Angers, Service d'hépato-gastroentérologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

group verum

group placebo

Arm Description

Drug: Irbesartan

Outcomes

Primary Outcome Measures

Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00265642

First Posted

December 14, 2005

Last Updated

February 6, 2014

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00265642

Brief Title

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Acronym

Fibrosar

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic, irbesartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

166 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group verum

Arm Type

Experimental

Arm Description

Drug: Irbesartan

Arm Title

group placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Irbesartan

Intervention Description

one tablet of 150 mg/d during 2 years

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

one tablet per day during 2 years

Primary Outcome Measure Information:

Title

Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24

Time Frame

at M24

Secondary Outcome Measure Information:

Title

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

Time Frame

at M24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Cales, MD

Organizational Affiliation

CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fabrice Carrat, MD

Organizational Affiliation

Inserm U707 France

Official's Role

Study Chair

Facility Information:

Facility Name

CHU Angers, Service d'hépato-gastroentérologie

City

Angers

ZIP/Postal Code

49933 cedex 09

Country

France

12. IPD Sharing Statement

Links:

URL

http://www.anrs.fr

Description

Related Info

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Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

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