Role of FXR in Hepatitis C Virus Replication

NCT01492998 | Terminated

• 1 other identifier: 2008.501-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C virus; Biliary salts; Farnesoid X receptor; Guggulsterone

Outcome Measures

Primary Outcomes (1)

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

  One week

Secondary Outcomes (1)

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

  One week

Study Arms (1)

Guggulsterone

EXPERIMENTAL

One arm of 15 chronically HCV genotype one infected patients

Other: guggulsterone, a natural FXR antagonist.

Interventions

guggulsterone, a natural FXR antagonist. OTHER

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

Guggulsterone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu

Lyon, 69288, France

Location

Related Publications (1)

• 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.

  PMID: 23241251 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

pregna-4,17-diene-3,16-dione

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Trépo, MD, Prof.

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Marianne Maynard, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: December 15, 2011
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: December 15, 2011

Record last verified: 2010-09

Locations

FR (1)