Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

NCT00265642 | Completed Phase 3 DMC

• 2 other identifiers: ANRS HC 19 Fibrosar2005-006027-37
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; irbesartan

Outcome Measures

Primary Outcomes (1)

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

  at M24

Secondary Outcomes (1)

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

  at M24

Study Arms (2)

group verum

EXPERIMENTAL

Drug: Irbesartan

Drug: Irbesartan

group placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Irbesartan DRUG

one tablet of 150 mg/d during 2 years

group verum

placebo DRUG

one tablet per day during 2 years

group placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• patients without antiviral therapy
• contraindication to anti viral treatment
• non responders or relapsers patients to past antiviral treatment

You may not qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Sanofi: collaborator

Study Sites (1)

CHU Angers, Service d'hépato-gastroentérologie

Angers, 49933 cedex 09, France

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Paul Cales, MD

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

  PRINCIPAL INVESTIGATOR

• Fabrice Carrat, MD

  Inserm U707 France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: October 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)