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

ConditionHepatitis E

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Elecsys Anti-HEV IgG, IgM
Diagnostic test
Diagnostic test used to determine antibodies in blood and serum.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Organ DonorsExperimental treatment 1 intervention

Group B: Cell DonorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

Source ClinicalTrials.gov

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