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Role of FXR in Hepatitis C Virus Replication (GGST)
This study has been terminated.
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01492998
First received: September 23, 2010
Last updated: December 14, 2011
Last verified: September 2010
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Purpose
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.
| Condition | Intervention |
|---|---|
| Chronic Hepatitis C | Other: guggulsterone, a natural FXR antagonist. |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. [ Time Frame: One week ]
Secondary Outcome Measures:
- Modification of the fraction of the circulating viral forms associated with apolipoprotein B [ Time Frame: One week ]
| Enrollment: | 15 |
| Study Start Date: | January 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Guggulsterone
One arm of 15 chronically HCV genotype one infected patients
|
Other: guggulsterone, a natural FXR antagonist.
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
- Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
- METAVIR score < F4
Exclusion Criteria:
- Alcohol intake > 20 g/day
- Immuno - suppressive therapy
- Obesity BMI > 30, diabetes
- Dyslipidemia requiring specific therapy
- Liver cirrhosis or carcinoma
- HIV or HBV co-infections
- Other liver diseases
- Major organ failures
- Therapy with cytochrome P450 metabolized drugs
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01492998
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492998
Locations
| France | |
| Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu | |
| Lyon, France, 69288 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Christian Trépo, MD, Prof. | Hospices Civils de Lyon |
| Principal Investigator: | Marianne Maynard, MD | Hospices Civils de Lyon |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01492998 History of Changes |
| Other Study ID Numbers: |
2008.501-02 |
| Study First Received: | September 23, 2010 |
| Last Updated: | December 14, 2011 |
Keywords provided by Hospices Civils de Lyon:
|
Hepatitis C virus Biliary salts Farnesoid X receptor Guggulsterone |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on September 21, 2017