Trial record 2 of 770 for:
"Hepatitis C, Chronic"
Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
This study is ongoing, but not recruiting participants.
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
Sanofi
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00265642
First received: December 14, 2005
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: Irbesartan Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C |
Resource links provided by NLM:
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- Assessment of liver fibrosis changes by measurement of area of fibrosis (morphometry)at M24 [ Time Frame: at M24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) [ Time Frame: at M24 ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: group verum
Drug: Irbesartan
|
Drug: Irbesartan
one tablet of 150 mg/d during 2 years
|
| Placebo Comparator: group placebo |
Drug: placebo
one tablet per day during 2 years
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265642
Locations
| France | |
| CHU Angers, Service d'hépato-gastroentérologie | |
| Angers, France, 49933 cedex 09 | |
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sanofi
Investigators
| Principal Investigator: | Paul Cales, MD | CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09 |
| Study Chair: | Fabrice Carrat, MD | Inserm U707 France |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
| ClinicalTrials.gov Identifier: | NCT00265642 History of Changes |
| Other Study ID Numbers: | 2005-006027-37, ANRS HC 19 Fibrosar |
| Study First Received: | December 14, 2005 |
| Last Updated: | July 5, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
Hepatitis C, Chronic irbesartan |
Additional relevant MeSH terms:
|
Hepatitis C, Chronic Fibrosis Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Irbesartan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013