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RecruitingNCT06457438Updated Jun 13, 2024

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

An interventional study of Elecsys Anti-HEV IgG, IgM in Hepatitis E, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2022, registered Jun 2024).
  • Started Jan 2022; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatitis E

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Keywords

  • Hepatitis E
  • Organ Donor
  • Cell Donor
  • HEV RNA
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In context

Hepatitis E

37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.

This study's planned enrollment of 300 is close to the median of 330 across 26 interventional studies indexed under Hepatitis E.

Browse Hepatitis E studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.

Browse University Hospital Ostrava studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients indicated for organ or cell donation

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Organ Donors

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

    Diagnostic Test: Elecsys Anti-HEV IgG, IgM

  • Experimental
    Cell Donors

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

    Diagnostic Test: Elecsys Anti-HEV IgG, IgM

Interventions

  • Diagnostic testElecsys Anti-HEV IgG, IgM

    Diagnostic test used to determine antibodies in blood and serum.

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What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

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

    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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region 708 52, Czechia
    Recruiting
    • Jiří Hynčica · Contactjiri.hyncica@fno.cz · 0042059737
    • Hana Slepčanová, Mgr. · Principal investigator
    • Tomáš Glac, Mgr. · Sub investigator
    • Šárka Blahutová, MD · Sub investigator
    • Ondřej Šušol, MD · Sub investigator
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References and documents

Publications

  • 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. PubMed 28194857 ↗
  • 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. PubMed 31284447 ↗
  • 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. PubMed 29154369 ↗
  • 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. PubMed 26174470 ↗
  • 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. PubMed 25755504 ↗
  • 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. PubMed 28374592 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06457438
Lead sponsor
University Hospital Ostrava
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
Jan 1, 2022
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jun 13, 2024

Study contacts

Jiří Hynčica
Contact
jiri.hyncica@fno.cz
0042059737 ext. 2587
Hana Slepčanová, Mgr.
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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