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

• Conditions: HCV Infection

• Registration Number: NCT00213707
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-24
• Last Update Posted: 2009-02-25
• Primary Completion: 2010-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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(+)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Function of blood circulating DC at day 7 and 1, 3, 6, 9, 12 months, 2 and 5 years after liver transplantation depending on the clinical outcome (mild or severe hepatitis, cirrhosis).	5 years

Trial Locations

Locations (1)

Francoise Stoll-Keller; 🇫🇷 Strasbourg, France