Role of FXR in Hepatitis C Virus Replication

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01492998

Acronym

GGST

Enrollment

Registered

2011-12-15

Start date

2010-01-31

Completion date

Unknown

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

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

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.

Interventions

OTHERguggulsterone, a natural FXR antagonist.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.	One week

Secondary

Measure	Time frame
Modification of the fraction of the circulating viral forms associated with apolipoprotein B	One week

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026