Role of FXR in Hepatitis C Virus Replication

Chronic Hepatitis C Clinical Trial

— GGST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01492998
• Other study ID #: 2008.501-02
• Status: Terminated
• Phase: N/A
• First received: September 23, 2010
• Last updated: December 14, 2011
• Start date: January 2010

Study information

• Verified date: September 2010
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Other:
• guggulsterone, a natural FXR antagonist.
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone

Locations

Country	Name	City	State
France	Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.		One week	No
Secondary	Modification of the fraction of the circulating viral forms associated with apolipoprotein B		One week	No