CompletedPhase 3

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

France166 participantsStarted 2006-10

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at M24

Trial details

NCT IDNCT00265642

SponsorANRS, Emerging Infectious Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Hepatitis C, Chronic trials