Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study (HEV)
Primary Purpose
Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hepatitis E serology
Sponsored by
About this trial
This is an interventional screening trial for Transplantation focused on measuring Hepatitis E, Pediatric, Transplantation, Prevalence
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transplanted patients
Arm Description
All patients included are in the same arm.
Outcomes
Primary Outcome Measures
Hepatitis E virus prevalence in pediatric transplanted patients
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.
Secondary Outcome Measures
Correlation between HEV prevalence and the different types of transplantation
Correlation between HEV prevalence and the different types of transplantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02809885
Brief Title
Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Acronym
HEV
Official Title
Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2013 (Actual)
Primary Completion Date
December 19, 2017 (Anticipated)
Study Completion Date
December 19, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation
Keywords
Hepatitis E, Pediatric, Transplantation, Prevalence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transplanted patients
Arm Type
Experimental
Arm Description
All patients included are in the same arm.
Intervention Type
Biological
Intervention Name(s)
Hepatitis E serology
Primary Outcome Measure Information:
Title
Hepatitis E virus prevalence in pediatric transplanted patients
Time Frame
Day 1
Title
Hepatitis E virus prevalence in pediatric transplanted patients
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation between HEV prevalence and the different types of transplantation
Time Frame
Day 1
Title
Correlation between HEV prevalence and the different types of transplantation
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noémie Laverdure, MD
Phone
698166674
Ext
+33
Email
noemie.laverdure@free.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alain LACHAUX, MD
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémie Laverdure, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
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