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Role of FXR in Hepatitis C Virus Replication

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliKuachishwa
Wadhamini
Hospices Civils de Lyon

Maneno muhimu

Kikemikali

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.

Tarehe

Imethibitishwa Mwisho: 08/31/2010
Iliyowasilishwa Kwanza: 09/22/2010
Uandikishaji uliokadiriwa Uliwasilishwa: 12/13/2011
Iliyotumwa Kwanza: 12/14/2011
Sasisho la Mwisho Liliwasilishwa: 12/13/2011
Sasisho la Mwisho Lilichapishwa: 12/14/2011
Tarehe halisi ya kuanza kwa masomo: 12/31/2009
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 02/28/2010

Hali au ugonjwa

Chronic Hepatitis C

Uingiliaji / matibabu

Other: Guggulsterone

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
Experimental: Guggulsterone
One arm of 15 chronically HCV genotype one infected patients
Other: Guggulsterone
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 18 Years Kwa 18 Years
Jinsia Inastahiki KujifunzaMale
Hupokea Wajitolea wa AfyaNdio
Vigezo

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

Matokeo

Hatua za Matokeo ya Msingi

1. Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. [One week]

Hatua za Matokeo ya Sekondari

1. Modification of the fraction of the circulating viral forms associated with apolipoprotein B [One week]

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