Role of FXR in Hepatitis C Virus Replication (GGST)

December 14, 2011 updated by: Hospices Civils de Lyon

Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69288
        • Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
Time Frame: One week
One week

Secondary Outcome Measures

Outcome Measure
Time Frame
Modification of the fraction of the circulating viral forms associated with apolipoprotein B
Time Frame: One week
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Christian Trépo, MD, Prof., Hospices Civils de Lyon
  • Principal Investigator: Marianne Maynard, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 15, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.501-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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