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

NCT01090232 | Completed

• 2 other identifiers: 2009-A00945-522009 20
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 years

Secondary Outcomes (1)

• the incidence of HEV infection in kidney-transplant

  2 years

Study Arms (2)

chronic HEV infection

EXPERIMENTAL

in kidney-transplant recipients with chronic HEV infection

Other: blood samples

control

ACTIVE COMPARATOR

the host responses in kidney-transplant recipients without viral infection (controls)

Other: blood samples

Interventions

blood samples OTHER

chronic HEV infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Affected by another sharp or chronic viral infection

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

Related Publications (1)

• 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.

  PMID: 23072754 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• VALERIE MOAL

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

FR (1)