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NCT02809885 Clinical Trial

Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Transplantation Clinical Trial

— HEV  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02809885
Other study ID # 2013-810
Secondary ID
Status Recruiting
Phase N/A
First received June 20, 2016
Last updated August 8, 2017
Start date December 19, 2013
Est. completion date December 19, 2017

Study information
Verified date August 2017
Source Hospices Civils de Lyon
Contact Noémie Laverdure, MD
Phone 698166674
Email noemie.laverdure@free.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 226
Est. completion date December 19, 2017
Est. primary completion date December 19, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Hepatitis E serology

Locations
Country Name City State
France Hospices Civils de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatitis E virus prevalence in pediatric transplanted patients Day 1
Primary 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 Correlation between HEV prevalence and the different types of transplantation Day 1
Secondary Correlation between HEV prevalence and the different types of transplantation 6 months
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