Completed

NCT Number: NCT01090232

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.

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Key information

Conditions

Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

About this study

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 :

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,
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 years
Transplanted by a functional kidney
affected by a hepatitis E chronic
Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille
Having signed a consent informed about participation in the study

Exclusion criteria

Affected by another sharp or chronic viral infection

Treatment and study plan

Blood Samples

Other

Primary outcomes

analysethe the host responses in kidney-transplant recipients with chronic HEV infection

Time frame: 2 years

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.

Secondary outcomes

the incidence of HEV infection in kidney-transplant

Time frame: 2 years

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,

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille