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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Unknown

Conditions

Transplantation

Treatments

Biological: Hepatitis E serology

Study type

Interventional

Funder types

Other

Identifiers

NCT02809885
2013-810

Details and patient eligibility

About

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.

Enrollment

226 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

226 participants in 1 patient group

Transplanted patients
Experimental group
Description:
All patients included are in the same arm.
Treatment:
Biological: Hepatitis E serology

Trial contacts and locations

1

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Central trial contact

Alain LACHAUX, MD; Noémie Laverdure, MD

Data sourced from clinicaltrials.gov

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