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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213707
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : February 25, 2009
Information provided by:
University Hospital, Strasbourg, France

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

Condition or disease
HCV Infection

Study Type : Observational
Estimated Enrollment : 30 participants
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.
Study Start Date : May 2003
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2011

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U.S. FDA Resources

Primary Outcome Measures :
  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). [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Serum peripheral blood mononuclear cells

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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(+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00213707

Francoise Stoll-Keller
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Francoise Stoll-Keller, MD Hopitaux Universitaires de Strasbourg

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg Identifier: NCT00213707     History of Changes
Other Study ID Numbers: 2864
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France:
Dendritic cells
liver transplantation
hepatitis C virus
virological markers
biochemical markers
immunological markers
clinical markers

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections