Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Study acronym: Fibrosar
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Publications expanded, about 24 wordsv12
  2. Re-verified, no change to tracked fieldsv11
  3. Study completion date changed from estimate of Mar 2013 to Nov 2013
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Mar 2013 to Apr 2013
    v10
  4. Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis to ANRS, Emerging Infectious Diseasesv9
  5. Primary endpoint revisedv8 Show 11 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 166
    • Primary and study completion dates: Mar 2013
    • Start date: Sep 2006 to Oct 2006
    • Interventions: Irbesartan (Drug) to Irbesartan (Drug), placebo (Drug)
    • Eligibility criteria revised
    • Secondary endpoint revised
    • Study description revised
    • Study site revised
    • Collaborator revised
    • Study arms: 0 to 2
Show 6 earlier versionsHide 6 earlier versions
  1. 3 versions Re-verified since Mar 29, 2007, no change to tracked fieldsv5-v7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  3. Start date: Jan 2006 to Sep 2006
    • Secondary endpoints: 4 to 1
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT00265642
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Sanofi
Conditions
(from sponsor)		 Hepatitis C, Chronic
Related terms Hepatitis C, Chronic
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov