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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-006027-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group verum | Experimental | Drug: Irbesartan |
|
| group placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan | Drug | one tablet of 150 mg/d during 2 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 | at M24 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry) | at M24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Cales, MD | CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09 | Principal Investigator |
| Fabrice Carrat, MD | Inserm U707 France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers, Service d'hépato-gastroentérologie | Angers | 49933 cedex 09 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Cales, Paul, et al. "Irbesartan for severe fibrosis in chronic hepatitis C: a double-blind randomized trial (ANRS HC19 Fibrosar): 454." Hepatology 60 (2014): 423A-424A. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| placebo |
| Drug |
one tablet per day during 2 years |
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |