Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors

Not Applicable

Recruiting

• Conditions: Hepatitis E
• Interventions: Diagnostic Test: Elecsys Anti-HEV IgG, IgM

• Registration Number: NCT06457438
• Lead Sponsor: University Hospital Ostrava

Brief Summary

In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

Detailed Description

At the Department of Laboratory Medicine of the Faculty of Medicine of the Faculty of Medicine of the National University of Health Sciences, human tissue and cells from donors will be examined for the assessment of health eligibility and donor selection according to Decree No. 422/2008 Coll. According to the current legislation, the determination of IgG and IgM antibodies against HEV or the HEV RNA method is not part of the standard examination of human tissue and cell donors for the assessment of their health eligibility.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients indicated for organ or cell donation

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Organ Donors	Elecsys Anti-HEV IgG, IgM	Samples obtained from organ donors will be included in this study arm.
Cell Donors	Elecsys Anti-HEV IgG, IgM	Samples obtained from cell donors will be included in this study arm.

Primary Outcome Measures

Name	Time	Method
Prevalence of Hepatitis E in the study groups	2 years	The prevalence of Hepatitis E will be observed in both study groups, measured as the number of positive samples from the total number of samples.

Secondary Outcome Measures

Name	Time	Method
Presence of Hepatitis E (HEV) RNA in the study groups	2 years	The presence of HEV RNA will be observed in both study groups, measured as the number of positive samples from the total number of samples.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia