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Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02809885
Acronym
HEV
Enrollment
226
Registered
2016-06-22
Start date
2013-12-19
Completion date
2017-12-19
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplantation

Keywords

Hepatitis E, Pediatric, Transplantation, Prevalence

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.

Interventions

BIOLOGICALHepatitis E serology

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hepatitis E virus prevalence in pediatric transplanted patientsDay 1

Secondary

MeasureTime frame
Correlation between HEV prevalence and the different types of transplantationDay 1

Countries

France

Contacts

Primary ContactNoémie Laverdure, MD
noemie.laverdure@free.fr698166674
Backup ContactAlain LACHAUX, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026