Status:
TERMINATED
Role of FXR in Hepatitis C Virus Replication
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Chronic Hepatitis C
Eligibility:
MALE
18-60 years
Phase:
NA
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 H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01492998
Start Date
January 1 2010
Last Update
December 15 2011
Active Locations (1)
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1
Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu
Lyon, France, 69288