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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00265642
First received: December 14, 2005
Last updated: February 6, 2014
Last verified: July 2012
  Purpose

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 Intervention Phase
Hepatitis C, Chronic
Drug: Irbesartan
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [ Time Frame: at M24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: October 2006
Study Completion Date: November 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
France
CHU Angers, Service d'hépato-gastroentérologie
Angers, France, 49933 cedex 09
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT00265642     History of Changes
Other Study ID Numbers: 2005-006027-37, ANRS HC 19 Fibrosar
Study First Received: December 14, 2005
Last Updated: February 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Hepatitis C, Chronic
irbesartan

Additional relevant MeSH terms:
Hepatitis C, Chronic
Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014