Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
HEV
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2017
CompletedAugust 9, 2017
August 1, 2017
4 years
June 20, 2016
August 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hepatitis E virus prevalence in pediatric transplanted patients
Day 1
Hepatitis E virus prevalence in pediatric transplanted patients
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.
6 months
Secondary Outcomes (2)
Correlation between HEV prevalence and the different types of transplantation
Day 1
Correlation between HEV prevalence and the different types of transplantation
6 months
Study Arms (1)
Transplanted patients
EXPERIMENTALAll patients included are in the same arm.
Interventions
Eligibility Criteria
You may qualify if:
- \<18 years old
- transplantation (heart, kidney, lung or bone marrow)
- protocol acceptance by family
- social security available
You may not qualify if:
- protocol rejection by family
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Bron, 69500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Alain LACHAUX, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 22, 2016
Study Start
December 19, 2013
Primary Completion
December 19, 2017
Study Completion
December 19, 2017
Last Updated
August 9, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share