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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213707
First received: September 13, 2005
Last updated: February 24, 2009
Last verified: February 2009
  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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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
Study Population

Patients for liver transplantation indicated after chronic hepatitis C.

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(+)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213707

Locations
France
Francoise Stoll-Keller
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014