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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00265642 |
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Date of registration:
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14/12/2005 |
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Primary sponsor: |
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Public title:
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Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
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Scientific title:
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Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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166 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00265642 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Paul Cales, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09 |
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Name:
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Fabrice Carrat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm U707 France |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Chronic
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Intervention(s)
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Drug: Irbesartan
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Drug: placebo
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Primary Outcome(s)
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Assessment of liver fibrosis changes by measurement of area of fibrosis (morphometry)at M24
[Time Frame: at M24]
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Secondary Outcome(s)
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Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)
[Time Frame: at M24]
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Secondary ID(s)
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2005-006027-37
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ANRS HC 19 Fibrosar
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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