Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.
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.
1 other identifier
observational
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFebruary 25, 2009
February 1, 2009
7 years
September 13, 2005
February 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients for liver transplantation indicated after chronic hepatitis C.
You may qualify if:
- 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.
You may not qualify if:
- HIV(+), HBV(+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Francoise Stoll-Keller
Strasbourg, France
Biospecimen
Serum peripheral blood mononuclear cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francoise Stoll-Keller, MD
Hopitaux Universitaires de Strasbourg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2003
Primary Completion
May 1, 2010
Study Completion
May 1, 2011
Last Updated
February 25, 2009
Record last verified: 2009-02