An interventional study of blood samples and blood samples in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-01.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable and Interventional
Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.
Therefore, the major goal of the study is to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
Other minor goals are :
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 17 is below the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Exclusion Criteria:
in kidney-transplant recipients with chronic HEV infection
Other: blood samples
the host responses in kidney-transplant recipients without viral infection (controls)
Other: blood samples
analysethe the host responses in kidney-transplant recipients with chronic HEV infection
to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
Time frame: 2 years
the incidence of HEV infection in kidney-transplant
to assess the incidence of HEV infection in kidney-transplant recipients from south-eastern France, to study the risk factors, and to describe the clinical features and outcomes of chronic HEV infection in kidney-transplant recipients,
Time frame: 2 years
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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