Clinical Trial: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

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.


Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: June 20, 2016
Date Started: December 2013
Date Completion: December 2016
Last Updated: June 22, 2016
Last Verified: June 2016