Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

NCT ID: NCT02809885

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-19

Study Completion Date

2017-12-19

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.

Detailed Description

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Conditions

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Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Transplanted patients

All patients included are in the same arm.

Group Type EXPERIMENTAL

Hepatitis E serology

Intervention Type BIOLOGICAL

Interventions

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Hepatitis E serology

Intervention Type BIOLOGICAL

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Noémie Laverdure, MD

Role: CONTACT

698166674 ext. +33

Alain LACHAUX, MD

Role: CONTACT

Facility Contacts

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Noémie Laverdure, MD

Role: primary

Other Identifiers

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2013-810

Identifier Type: -

Identifier Source: org_study_id

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