An interventional study of Hepatitis E serology in Transplantation, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Screening
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.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's planned enrollment of 226 is below the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2013 (actual). Primary completion is estimated for Dec 2017, 48 months after the start.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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