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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00213707
Other study ID # 2864
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 13, 2005
Last updated February 24, 2009
Start date May 2003
Est. completion date May 2011

Study information

Verified date February 2009
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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(+)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Francoise Stoll-Keller Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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