ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 3155 for:    "Hepatitis, Viral, Human"

Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study (HEV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02809885
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.

HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.

In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.

This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.


Condition or disease Intervention/treatment Phase
Transplantation Biological: Hepatitis E serology Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Actual Study Start Date : December 19, 2013
Estimated Primary Completion Date : December 19, 2017
Estimated Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transplanted patients
All patients included are in the same arm.
Biological: Hepatitis E serology



Primary Outcome Measures :
  1. Hepatitis E virus prevalence in pediatric transplanted patients [ Time Frame: Day 1 ]
  2. Hepatitis E virus prevalence in pediatric transplanted patients [ Time Frame: 6 months ]
    Hepatitis E virus (HEV) serology : IgG & IgM, and PCR HEV. If serology is positive a second serology will be performed 6 months after in order to detect chronic infection.


Secondary Outcome Measures :
  1. Correlation between HEV prevalence and the different types of transplantation [ Time Frame: Day 1 ]
  2. Correlation between HEV prevalence and the different types of transplantation [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • <18 years old
  • transplantation (heart, kidney, lung or bone marrow)
  • protocol acceptance by family
  • social security available

Exclusion Criteria:

  • protocol rejection by family

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): NCT02809885


Contacts
Contact: Noémie Laverdure, MD 698166674 ext +33 noemie.laverdure@free.fr
Contact: Alain LACHAUX, MD

Locations
France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Noémie Laverdure, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02809885     History of Changes
Other Study ID Numbers: 2013-810
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
Hepatitis E
Pediatric
Transplantation
Prevalence

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