- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02809885
Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study (HEV)
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noémie Laverdure, MD
- Phone Number: +33 698166674
- Email: noemie.laverdure@free.fr
Study Contact Backup
- Name: Alain LACHAUX, MD
Study Locations
-
-
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Bron, France, 69500
- Recruiting
- Hospices Civils de Lyon
-
Contact:
- Noémie Laverdure, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transplanted patients
All patients included are in the same arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hepatitis E virus prevalence in pediatric transplanted patients
Time Frame: Day 1
|
Day 1
|
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Hepatitis E virus prevalence in pediatric transplanted patients
Time Frame: 6 months
|
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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between HEV prevalence and the different types of transplantation
Time Frame: Day 1
|
Day 1
|
Correlation between HEV prevalence and the different types of transplantation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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