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Role of FXR in Hepatitis C Virus Replication

NCT ID: NCT01492998

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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Hepatitis C virus Biliary salts Farnesoid X receptor Guggulsterone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Guggulsterone

One arm of 15 chronically HCV genotype one infected patients

Group Type EXPERIMENTAL

guggulsterone, a natural FXR antagonist.

Intervention Type OTHER

Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone

Interventions

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guggulsterone, a natural FXR antagonist.

Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Trépo, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Marianne Maynard, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23241251 (View on PubMed)

Other Identifiers

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2008.501-02

Identifier Type: -

Identifier Source: org_study_id