Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Study Overview
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Brief Summary
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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.

Official Title
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Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Conditions
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Transplantation

Intervention / Treatment
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* Biological: Hepatitis E serology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplanted patients<br>All patients included are in the same arm. | Biological: Hepatitis E serology<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HEV prevalence and the different types of transplantation |  | Day 1 | 
| Correlation between HEV prevalence and the different types of transplantation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis E, Pediatric, Transplantation, Prevalence