| Registry | NCT06457438 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
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| Enrollment | 300 (Estimated) |
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| Sponsor | University Hospital Ostrava (Other) |
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| Conditions | Hepatitis E |
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| Interventions | Elecsys Anti-HEV IgG, IgM (Diagnostic test) |
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| Dates | start 2022-01-01, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2024-06-13, last updated 2024-06-13 |
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| Locations | 1 site in Czechia |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hepatitis E All trials of Elecsys Anti-HEV IgG, IgM
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Organ Donors | Experimental | Diagnostic Test: Elecsys Anti-HEV IgG, IgM | Samples obtained from organ donors will be included in this study arm. |
| Cell Donors | Experimental | Diagnostic Test: Elecsys Anti-HEV IgG, IgM | Samples obtained from cell donors will be included in this study arm. |
- Elecsys Anti-HEV IgG, IgM (Diagnostic test): Diagnostic test used to determine antibodies in blood and serum.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
+Eligibility
Sex: All
Inclusion Criteria:
\- patients indicated for organ or cell donation
Exclusion Criteria:
\- none
+Locations (1)
| Facility | City | Country | Status |
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| University Hospital Ostrava | Ostrava, Moravian-Silesian Region | Czechia | Recruiting |
+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28374592
- Results publication: Slepcanova H, Glac T, Konde A, Harazimova A, Kusnierova P. Molecular and serodetection of hepatitis E virus among organ donors in the Czech Republic. BMC Infect Dis. 2026 Jan 16;26(1):319. doi: 10.1186/s12879-026-12567-5. PMID 41545967
+Investigators
- Hana Slepčanová, Mgr., Principal investigator, University Hospital Ostrava