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Role of FXR in Hepatitis C Virus Replication (GGST)

This study has been terminated.
Sponsor:
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
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modification of the fraction of the circulating viral forms associated with apolipoprotein B [ Time Frame: One week ] [ Designated as safety issue: No ]

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
Genders 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
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

No publications provided by Hospices Civils de Lyon

Additional 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Hepatitis C virus
Biliary salts
Farnesoid X receptor
Guggulsterone

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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 May 19, 2013