Role of FXR in Hepatitis C Virus Replication (GGST)
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ClinicalTrials.gov Identifier: NCT01492998 |
Recruitment Status
:
Terminated
First Posted
: December 15, 2011
Last Update Posted
: December 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Other: guggulsterone, a natural FXR antagonist. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | March 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Guggulsterone
One arm of 15 chronically HCV genotype one infected patients
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Other: guggulsterone, a natural FXR antagonist.
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone
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- Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. [ Time Frame: One week ]
- Modification of the fraction of the circulating viral forms associated with apolipoprotein B [ Time Frame: One week ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492998
France | |
Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu | |
Lyon, France, 69288 |
Principal Investigator: | Christian Trépo, MD, Prof. | Hospices Civils de Lyon | |
Principal Investigator: | Marianne Maynard, MD | Hospices Civils de Lyon |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT01492998 History of Changes |
Other Study ID Numbers: |
2008.501-02 |
First Posted: | December 15, 2011 Key Record Dates |
Last Update Posted: | December 15, 2011 |
Last Verified: | September 2010 |
Keywords provided by Hospices Civils de Lyon:
Hepatitis C virus Biliary salts Farnesoid X receptor Guggulsterone |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |