Last reviewed · How we verify
NCT06631560: HepE-Onko-BB
Hepatitis E Virus Infection in Oncological Patients
NA trial testing ELISA testing in Hepatitis E Infection in 197 participants. Completed in 1 October 2024.
29 October 2021
Quick facts
| Lead sponsor | Medizinische Hochschule Brandenburg Theodor Fontane |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 197 |
| Start date | 1 September 2020 |
| Primary completion | 29 October 2021 |
| Estimated completion | 1 October 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- ELISA testing
Conditions studied
- Hepatitis E Infection — all drugs for Hepatitis E Infection →
- Hepatitis; Epidemic — all drugs for Hepatitis; Epidemic →
- Oncologic Disorders — all drugs for Oncologic Disorders →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06631560
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06631560 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medizinische Hochschule Brandenburg Theodor Fontane
- Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06631560.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing