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

June 7, 2024 updated by: University Hospital Ostrava
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Hana Slepčanová, Mgr.
        • Sub-Investigator:
          • Tomáš Glac, Mgr.
        • Sub-Investigator:
          • Šárka Blahutová, MD
        • Sub-Investigator:
          • Ondřej Šušol, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- patients indicated for organ or cell donation

Exclusion Criteria:

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Organ Donors
Samples obtained from organ donors will be included in this study arm.
Diagnostic test: Elecsys Anti-HEV IgG, IgM
Diagnostic test used to determine antibodies in blood and serum.
Experimental: Cell Donors
Samples obtained from cell donors will be included in this study arm.
Diagnostic test: Elecsys Anti-HEV IgG, IgM
Diagnostic test used to determine antibodies in blood and serum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hepatitis E in the study groups
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Hepatitis E (HEV) RNA in the study groups
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Hana Slepčanová, Mgr., University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/OR-FNOs/2024 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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