NCT00265642

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Irbesartan	one tablet of 150 mg/d during 2 years
DRUG	placebo	one tablet per day during 2 years

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-04-01
• Completion: 2013-11-01
• First posted: 2005-12-15
• Last updated: 2026-04-13

Locations

1 site across 1 country: France