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

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ClinicalTrials.gov Identifier: NCT01090232
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection Other: blood samples Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chronic HEV infection
in kidney-transplant recipients with chronic HEV infection
Other: blood samples
Active Comparator: control
the host responses in kidney-transplant recipients without viral infection (controls)
Other: blood samples



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090232


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: VALERIE MOAL Assistance Publique Hopitaux De Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01090232     History of Changes
Other Study ID Numbers: 2009-A00945-52
2009 20 ( Other Identifier: ap hm )
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Hepatitis E
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections