Role of FXR in Hepatitis C Virus Replication (GGST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492998
Recruitment Status : Terminated
First Posted : December 15, 2011
Last Update Posted : December 15, 2011
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492998

Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu
Lyon, France, 69288
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Christian Trépo, MD, Prof. Hospices Civils de Lyon
Principal Investigator: Marianne Maynard, MD Hospices Civils de Lyon

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon 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

Additional relevant MeSH terms:
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