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NCT06369740
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
trial testing Case scenarios - questionnaire in Hemophilia a in 74 participants. Completed in 25 August 2024.
25 August 2024
Quick facts
| Lead sponsor | Enzyre B.V. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 74 |
| Start date | 22 August 2024 |
| Primary completion | 25 August 2024 |
| Estimated completion | 25 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Case scenarios - questionnaire
- Case scenarios - Focus groups
- Use scenarios - Usability test
- Use scenarios - interview
Conditions studied
- Hemophilia a — all drugs for Hemophilia a →
Sponsor
Enzyre B.V.
Who can join
12 and older, any sex, with Hemophilia a. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This observational study consists of two parts. In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are: * How is coagulation lab testing for patients with hemophilia A currently organized? * What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A? Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Measuring FVIII Activity and Thrombin Generation Simultaneously With a Novel Point of Care Platform (EnzySystem HemA): Qualitative Usability Evaluation.
Bavinck A, Schols SEM, Teunissen W, Shapiro A, et al · · 2025 · cited 1× · PMID 41100594 · DOI 10.2196/77621 -
Acceptability and Determinants for Implementation of the EnzySystem, a Novel Near-Patient Testing Platform for Haemophilia A.
Bavinck AP, Davis K, van Engelshoven L, van Lier MG, et al · · 2026 · PMID 41403342 · DOI 10.1111/hae.70191
Verify or expand the search:
- PubMed search for NCT06369740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hemophilia a
Currently open trials in the same condition.
- NCT06565481 — Measurement Properties in People with Hemophilia · NA · recruiting
- NCT06702579 — Home Monitoring in Hemophilia a · recruiting
Other Enzyre B.V. trials
Trials by the same sponsor.
- NCT06357572 — Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem · completed
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 NCT06369740 (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 Enzyre B.V.
- Last refreshed: 29 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/NCT06369740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing