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Sponsored by: |
University Hospital, Strasbourg, France |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00213707 |
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
Condition |
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HCV Infection |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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. |
Serum peripheral blood mononuclear cells
Estimated Enrollment: | 30 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients for liver transplantation indicated after chronic hepatitis C.
Inclusion Criteria:
Liver transplanted HCV infected patients :
Control patients :
Exclusion Criteria:
France | |
Francoise Stoll-Keller | |
Strasbourg, France |
Principal Investigator: | Francoise Stoll-Keller, MD | Hopitaux Universitaires de Strasbourg |
Responsible Party: | Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg ( Christine GEILLER ) |
Study ID Numbers: | 2864 |
Study First Received: | September 13, 2005 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00213707 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Dendritic cells liver transplantation hepatitis C virus quasispecies |
virological markers biochemical markers immunological markers clinical markers |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Hepatitis C Recurrence |
Virus Diseases Hepatitis Communicable Diseases RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C Infection |