Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|
|
HCV Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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. |
- 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). [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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) |
Eligibility| 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 :
- 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(+)
Contacts and Locations| France | |
| Francoise Stoll-Keller | |
| Strasbourg, France | |
| Principal Investigator: | Francoise Stoll-Keller, MD | Hopitaux Universitaires de Strasbourg |
More Information
No publications provided
| Responsible Party: | Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg |
| ClinicalTrials.gov Identifier: | NCT00213707 History of Changes |
| Other Study ID Numbers: | 2864 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 24, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Strasbourg, France:
|
Dendritic cells liver transplantation hepatitis C virus quasispecies |
virological markers biochemical markers immunological markers clinical markers |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C End Stage Liver Disease Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Liver Failure Hepatic Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013