Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.

NCT ID: NCT00213707

Last Updated: 2009-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2011-05-31

Brief Summary

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Re-infection of the liver graft occurs universally following liver transplantation for HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is extremely variable from one patient to another. The host and viral factors being responsible for the different course of HCV infection are poorly understood. Our study will focus on dendritic cells which are known to play a critical role in the control of viral infection. Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients transplanted for HCV-related disease and 10 controls transplanted for non HCV-related disease. Blood samples will be taken just before transplantation and at different time -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be enumerated. HCV quasispecies evolution will be analysed. This study may help to define prognostic markers on progression of hepatitis C in liver transplantation and allow the development of new immunotherapeutic drugs

Detailed Description

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Conditions

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HCV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Liver transplanted HCV infected patients :

* Adults, HIV(-),HBV(-)
* liver transplanted for an end stage liver disease associated to HCV.
* Genotype determined
* written agreement to participate to the study

Control patients :

* Adults, HIV(-), HBV(-), HCV(-)
* liver transplanted for a non HCV liver disease
* written agreement to participate to the study.

Exclusion Criteria

* HIV(+), HBV(+)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Principal Investigators

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Francoise Stoll-Keller, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Universitaires de Strasbourg

Locations

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Francoise Stoll-Keller

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2864

Identifier Type: -

Identifier Source: org_study_id

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