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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01090232
Enrollment
17
Registered
2010-03-19
Start date
2010-02-28
Completion date
2012-08-31
Last updated
2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

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.

Interventions

OTHERblood samples

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
analysethe the host responses in kidney-transplant recipients with chronic HEV infection2 yearsto 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

MeasureTime frameDescription
the incidence of HEV infection in kidney-transplant2 yearsto 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,

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026