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Role of FXR in Hepatitis C Virus Replication (GGST)

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ClinicalTrials.gov Identifier: NCT01492998
Recruitment Status : Terminated
First Posted : December 15, 2011
Last Update Posted : December 15, 2011
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Other: guggulsterone, a natural FXR antagonist. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. [ Time Frame: One week ]

Secondary Outcome Measures :
  1. Modification of the fraction of the circulating viral forms associated with apolipoprotein B [ Time Frame: One week ]

Eligibility Criteria
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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 (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: September 2010

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