CClinicalTrials.gg
CompletedNCT00265642FibrosarUpdated Apr 13, 2026

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

A Phase 3 interventional study of Irbesartan and placebo in Hepatitis C, Chronic, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Hepatitis C, Chronic
  • irbesartan
03

In context

Hepatitis C, Chronic

1,073 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 166 is above the median of 90 across 775 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • hepatocellular carcinoma
  • HIV
  • alcool abuser
  • cirrhosis
  • anti-fibrotic treatment
  • pregnancy or breast feeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    group verum

    Drug: Irbesartan

    Drug: Irbesartan

  • Placebo comparator
    group placebo

    Drug: placebo

Interventions

  • DrugIrbesartan

    one tablet of 150 mg/d during 2 years

  • Drugplacebo

    one tablet per day during 2 years

06

What researchers measure

Primary outcomes

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

    Time frame: at M24

Secondary outcomes

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

    Time frame: at M24

07

Study locations

1 site
  • CHU Angers, Service d'hépato-gastroentérologie
    Angers, 49933 cedex 09, France
08

References and documents

Publications

  • Cales, Paul, et al. "Irbesartan for severe fibrosis in chronic hepatitis C: a double-blind randomized trial (ANRS HC19 Fibrosar): 454." Hepatology 60 (2014): 423A-424A.

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00265642
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Dec 15, 2005
Start date
Oct 2006
Primary completion
Apr 2013
Completion
Nov 2013
Last update
Apr 13, 2026

Study contacts

Paul Cales, MD
principal investigator · CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
Fabrice Carrat, MD
study chair · Inserm U707 France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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