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Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Treatments

Other: blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT01090232
2009 20 (Other Identifier)
2009-A00945-52

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

chronic HEV infection
Experimental group
Description:
in kidney-transplant recipients with chronic HEV infection
Treatment:
Other: blood samples
Other: blood samples
control
Active Comparator group
Description:
the host responses in kidney-transplant recipients without viral infection (controls)
Treatment:
Other: blood samples
Other: blood samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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