Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study (HEV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02809885|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : August 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Transplantation||Biological: Hepatitis E serology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study|
|Actual Study Start Date :||December 19, 2013|
|Estimated Primary Completion Date :||December 19, 2017|
|Estimated Study Completion Date :||December 19, 2017|
Experimental: Transplanted patients
All patients included are in the same arm.
|Biological: Hepatitis E serology|
- Hepatitis E virus prevalence in pediatric transplanted patients [ Time Frame: Day 1 ]
- 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.
- Correlation between HEV prevalence and the different types of transplantation [ Time Frame: Day 1 ]
- Correlation between HEV prevalence and the different types of transplantation [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809885
|Contact: Noémie Laverdure, MD||698166674 ext +firstname.lastname@example.org|
|Contact: Alain LACHAUX, MD|
|Hospices Civils de Lyon||Recruiting|
|Bron, France, 69500|
|Contact: Noémie Laverdure, MD|