Clinical trial NCT00213707: Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.
Official title: Liver Transplanted Patients for HCV Related End Stage Liver Disease.Functional Role of Blood Circulating Dendritic Cells in the Pathogenesis of Hepatitis C Virus Infection During Liver Transplantation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV Infection
Keywords: Dendritic cells
liver transplantation
hepatitis C virus
quasispecies
virological markers
biochemical markers
immunological markers
clinical markers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for liver transplantation indicated after chronic hepatitis C.

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


Eligibility criteria: 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(+)

Primary outcomes:
measure: 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).
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Francoise Stoll-Keller
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Francoise Stoll-Keller, MD
role: PRINCIPAL_INVESTIGATOR
References: