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Clinical Trials/NCT01492998
NCT01492998TerminatedNot Applicable

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

Hospices Civils de Lyon2 sites in 1 country15 target enrollmentStarted: January 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
15
Locations
2
Primary Endpoint
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: One week

Secondary Outcomes

  • Modification of the fraction of the circulating viral forms associated with apolipoprotein B(One week)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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