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

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ClinicalTrials.gov Identifier: NCT00265642
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date  ICMJE December 14, 2005
First Posted Date  ICMJE December 15, 2005
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 [ Time Frame: at M24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
Assessment of hepatic fibrosis changes by measurement of area of fibrosis (image analysis method)at M24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
  • Assessment of hepatic fibrosis changes at M24 by:
  • - blood scores of fibrosis
  • - hyaluronate dosage
  • - prothrombin time and alpha 2 macroglobulinemia dosages
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
Official Title  ICMJE Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • Drug: Irbesartan
    one tablet of 150 mg/d during 2 years
  • Drug: placebo
    one tablet per day during 2 years
Study Arms  ICMJE
  • Experimental: group verum
    Drug: Irbesartan
    Intervention: Drug: Irbesartan
  • Placebo Comparator: group placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2012)
166
Original Enrollment  ICMJE
 (submitted: December 14, 2005)
200
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265642
Other Study ID Numbers  ICMJE 2005-006027-37
ANRS HC 19 Fibrosar
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor  ICMJE ANRS, Emerging Infectious Diseases
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Paul Cales, MD CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
Study Chair: Fabrice Carrat, MD Inserm U707 France
PRS Account ANRS, Emerging Infectious Diseases
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP