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Hemophilia A patients - case scenario focus groups for Hemophilia A

N/A
Waitlist Available
Research Sponsored by Enzyre B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Current management of Hemophilia A coagulation lab testing
Usability issues of the current POC in-vitro diagnostic device prototypes

Trial Design

4Treatment groups
Experimental Treatment
Group I: Hemophilia A patients - use scenariosExperimental Treatment2 Interventions
6 patients with hemophilia A aged 12 years and older that partake in the use scenarios usability evaluation
Group II: Hemophilia A patients - case scenario focus groupsExperimental Treatment2 Interventions
60 patients with hemophilia A aged 12 years and older that partake in the case scenario focus groups
Group III: Healthcare providers - use scenariosExperimental Treatment2 Interventions
6 healthcare providers with experience in the field of hemophilia A that partake in the use scenarios usability evaluation
Group IV: Healthcare providers - case scenario focus groupsExperimental Treatment2 Interventions
30 healthcare providers with experience in the field of hemophilia A that partake in the case scenario focus groups

Find a Location

Who is running the clinical trial?

Enzyre B.V.Lead Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
2 Trials studying Hemophilia A
46 Patients Enrolled for Hemophilia A
Indiana Hemophilia & Thrombosis CenterUNKNOWN
~68 spots leftby Sep 2025