Hepatitis E Clinical Trial
Official title:
Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients indicated for organ or cell donation Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 2 years |
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