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NCT06631560: HepE-Onko-BB

Hepatitis E Virus Infection in Oncological Patients

Completed NA Last updated 8 October 2024
What this trial tests

NA trial testing ELISA testing in Hepatitis E Infection in 197 participants. Completed in 1 October 2024.

Timeline
1 September 2020
Primary endpoint
29 October 2021
1 October 2024

Quick facts

Lead sponsorMedizinische Hochschule Brandenburg Theodor Fontane
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment197
Start date1 September 2020
Primary completion29 October 2021
Estimated completion1 October 2024
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Medizinische Hochschule Brandenburg Theodor Fontane

Who can join

Eligibility, any sex, with Hepatitis E Infection or Hepatitis; Epidemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Low Serological Agreement of Hepatitis E in Immunocompromised Cancer Patients: A Comparative Study of Three Anti-HEV Assays.
    Haller IE, Reinwald M, Kah J, Eggert FAM, et al · · 2025 · cited 1× · PMID 40265408 · DOI 10.3390/antib14020027

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Other Medizinische Hochschule Brandenburg Theodor Fontane trials

Trials by the same sponsor.

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