NCT06457438

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

June 7, 2024

Last Update Submit

June 7, 2024

Conditions

Hepatitis E

Keywords

Hepatitis EOrgan DonorCell DonorHEV RNA

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Hepatitis E in the study groups

    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 Outcomes (1)

  • Presence of Hepatitis E (HEV) RNA in the study groups

    2 years

Study Arms (2)

Organ Donors

EXPERIMENTAL

Samples obtained from organ donors will be included in this study arm.

Diagnostic Test: Elecsys Anti-HEV IgG, IgM

Cell Donors

EXPERIMENTAL

Samples obtained from cell donors will be included in this study arm.

Diagnostic Test: Elecsys Anti-HEV IgG, IgM

Interventions

Elecsys Anti-HEV IgG, IgMDIAGNOSTIC_TEST

Diagnostic test used to determine antibodies in blood and serum.

Cell DonorsOrgan Donors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients indicated for organ or cell donation

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Related Publications (6)

  • Tedder RS, Ijaz S, Kitchen A, Ushiro-Lumb I, Tettmar KI, Hewitt P, Andrews N. Hepatitis E risks: pigs or blood-that is the question. Transfusion. 2017 Feb;57(2):267-272. doi: 10.1111/trf.13976.

    PMID: 28194857BACKGROUND

  • Horvatits T, Schulze Zur Wiesch J, Lutgehetmann M, Lohse AW, Pischke S. The Clinical Perspective on Hepatitis E. Viruses. 2019 Jul 5;11(7):617. doi: 10.3390/v11070617.

    PMID: 31284447BACKGROUND

  • Kamar N, Izopet J, Pavio N, Aggarwal R, Labrique A, Wedemeyer H, Dalton HR. Hepatitis E virus infection. Nat Rev Dis Primers. 2017 Nov 16;3:17086. doi: 10.1038/nrdp.2017.86.

    PMID: 29154369BACKGROUND

  • Blasco-Perrin H, Madden RG, Stanley A, Crossan C, Hunter JG, Vine L, Lane K, Devooght-Johnson N, Mclaughlin C, Petrik J, Stableforth B, Hussaini H, Phillips M, Mansuy JM, Forrest E, Izopet J, Blatchford O, Scobie L, Peron JM, Dalton HR. Hepatitis E virus in patients with decompensated chronic liver disease: a prospective UK/French study. Aliment Pharmacol Ther. 2015 Sep;42(5):574-81. doi: 10.1111/apt.13309. Epub 2015 Jul 14.

    PMID: 26174470BACKGROUND

  • Kumar A, Saraswat VA. Hepatitis E and Acute-on-Chronic Liver Failure. J Clin Exp Hepatol. 2013 Sep;3(3):225-30. doi: 10.1016/j.jceh.2013.08.013. Epub 2013 Sep 16.

    PMID: 25755504BACKGROUND

  • Nemecek V, Butovicova P, Maly M, Dite P, Vertatova M, Vodickova I, Kriz B. [The prevalence of antibodies against Hepatitis E Virus in the Czech Republic: serological survey]. Epidemiol Mikrobiol Imunol. 2017 Winter;66(1):3-7. Czech.

    PMID: 28374592BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Hana Slepčanová, Mgr.

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737jiri.hyncica@fno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the study.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study subjects and their samples will be divided into two study groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 13, 2024

Study Start

January 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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

Locations

CZ(1)