Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection Clinical Trial
Official title:
Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
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 :
1. 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,
2. to compare the peripheral signature to a liver signature in the cases where a liver
biopsy is available. If peripheral and liver signatures are parallel, peripheral
signature may become a non-invasive tool of exploration of chronic HEV infection in
kidney-transplant recipients.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label