Clinical trial NCT01090232: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
Official title: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: analysethe the host responses in kidney-transplant recipients with chronic HEV infection
timeFrame: 2 years
Secondary outcomes:
measure: the incidence of HEV infection in kidney-transplant
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: VALERIE MOAL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moal V, Textoris J, Ben Amara A, Mehraj V, Berland Y, Colson P, Mege JL. Chronic hepatitis E virus infection is specifically associated with an interferon-related transcriptional program. J Infect Dis. 2013 Jan 1;207(1):125-32. doi: 10.1093/infdis/jis632. Epub 2012 Oct 16.