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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06457438

Enrollment

300

Registered

2024-06-13

Start date

2022-01-01

Completion date

2024-12-31

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E

Keywords

Hepatitis E, Organ Donor, Cell Donor, HEV RNA

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.

Interventions

DIAGNOSTIC_TESTElecsys Anti-HEV IgG, IgM

Diagnostic test used to determine antibodies in blood and serum.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

No masking will be used in the study.

Intervention model description

The study subjects and their samples will be divided into two study groups.

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

\- patients indicated for organ or cell donation

Exclusion criteria

\- none

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica

jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026