Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Not Applicable

• Conditions: Transplantation
• Interventions: Biological: Hepatitis E serology

• Registration Number: NCT02809885
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12-19
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-22
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

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

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Exclusion Criteria

• protocol rejection by family

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transplanted patients	Hepatitis E serology	All patients included are in the same arm.

Primary Outcome Measures

Name	Time	Method
Hepatitis E virus prevalence in pediatric transplanted patients	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

Name	Time	Method
Correlation between HEV prevalence and the different types of transplantation	6 months

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France