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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01090232
First received: March 18, 2010
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention
Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
Other: blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • analysethe the host responses in kidney-transplant recipients with chronic HEV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • the incidence of HEV infection in kidney-transplant [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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,


Estimated Enrollment: 18
Study Start Date: February 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090232

Contacts
Contact: valerie MOAL valerie.moal@ap-hm.fr

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

No publications provided by Assistance Publique Hopitaux De Marseille

Additional 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
Study First Received: March 18, 2010
Last Updated: April 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 22, 2014