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Role of FXR in Hepatitis C Virus Replication (GGST)

Primary Purpose

Chronic Hepatitis C

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
guggulsterone, a natural FXR antagonist.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C virus, Biliary salts, Farnesoid X receptor, Guggulsterone

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guggulsterone

Arm Description

One arm of 15 chronically HCV genotype one infected patients

Outcomes

Primary Outcome Measures

Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.

Secondary Outcome Measures

Modification of the fraction of the circulating viral forms associated with apolipoprotein B

Full Information

First Posted
September 23, 2010
Last Updated
December 14, 2011
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01492998
Brief Title
Role of FXR in Hepatitis C Virus Replication
Acronym
GGST
Official Title
Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Hepatitis C virus, Biliary salts, Farnesoid X receptor, Guggulsterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guggulsterone
Arm Type
Experimental
Arm Description
One arm of 15 chronically HCV genotype one infected patients
Intervention Type
Other
Intervention Name(s)
guggulsterone, a natural FXR antagonist.
Intervention Description
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone
Primary Outcome Measure Information:
Title
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Modification of the fraction of the circulating viral forms associated with apolipoprotein B
Time Frame
One week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Trépo, MD, Prof.
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Maynard, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu
City
Lyon
ZIP/Postal Code
69288
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23241251
Citation
Scholtes C, Andre P, Trepo C, Cornu C, Remontet L, Ecochard R, Bejan-Angoulvant T, Gueyffier F. Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial. Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.
Results Reference
derived

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Role of FXR in Hepatitis C Virus Replication

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