Clinical Trials Logo
  1. Home
  2. Transplantation
  3. NCT02809885
  4. Details
NCT02809885 Clinical Trial

Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Transplantation Clinical Trial

— HEV  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02809885
Other study ID # 2013-810
Secondary ID
Status Recruiting
Phase N/A
First received June 20, 2016
Last updated August 8, 2017
Start date December 19, 2013
Est. completion date December 19, 2017

Study information
Verified date August 2017
Source Hospices Civils de Lyon
Contact Noémie Laverdure, MD
Phone 698166674
Email noemie.laverdure@free.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 226
Est. completion date December 19, 2017
Est. primary completion date December 19, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Hepatitis E serology

Locations
Country Name City State
France Hospices Civils de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatitis E virus prevalence in pediatric transplanted patients Day 1
Primary 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. 6 months
Secondary Correlation between HEV prevalence and the different types of transplantation Day 1
Secondary Correlation between HEV prevalence and the different types of transplantation 6 months
See also
  Status Clinical Trial Phase
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Completed NCT00838357 - A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). Phase 3
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Completed NCT02560909 - Adjuvanted Influenza Vaccine in Stem Cell Transplant Phase 4
Active, not recruiting NCT01687192 - Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. Phase 2
Completed NCT00951977 - Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study N/A
Completed NCT00384137 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients Phase 3
Completed NCT00384202 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients Phase 3
Completed NCT00235664 - Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients N/A
Completed NCT03533049 - mHealth Family Self-Management N/A
Completed NCT02826213 - Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
Completed NCT00170170 - Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation N/A
Recruiting NCT06367244 - Transplant Wellness Program N/A
Recruiting NCT06166186 - Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy N/A
Recruiting NCT00493194 - Fibrosis in Renal Allografts Phase 4
Completed NCT00297310 - Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation Phase 4
Completed NCT01019811 - Innervated Sensory Cross-Finger Flap N/A
Completed NCT04376775 - Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation
Active, not recruiting NCT00166816 - The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients Phase 4