Role of FXR in Hepatitis C Virus Replication (GGST)

Civil Hospices of Lyon

Status: Terminated

Conditions: Chronic Hepatitis C

Treatments: Other: guggulsterone, a natural FXR antagonist.

Study type: Interventional

Funder types: Other

Identifiers

NCT01492998

2008.501-02

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Guggulsterone

Experimental group

Description:

One arm of 15 chronically HCV genotype one infected patients

Treatment:

Other: guggulsterone, a natural FXR antagonist.