- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213707
Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.
February 24, 2009 updated by: University Hospital, Strasbourg, France
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.
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Strasbourg, France
- Francoise Stoll-Keller
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients for liver transplantation indicated after chronic hepatitis C.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francoise Stoll-Keller, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Anticipated)
May 1, 2010
Study Completion (Anticipated)
May 1, 2011
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 25, 2009
Last Update Submitted That Met QC Criteria
February 24, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2864
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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