N/A
Completed N=86
Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO
Source: ClinicalTrials.gov NCT01959919 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Ease of Using Clotting Factor Treatment Score — 31.15 units on a scale — p=0.000
Summary
This study aims to investigate prospectively throughout a period of 3- 6 months and not to exceed 12 months (according to local therapeutic plans) patients experiences of treatment with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII compared to their previous delivery system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Using Clotting Factor Treatment Score |
31.15 | 0.000 sig |
| PRIMARY Time for Reconstructing the Drug |
6.247 | 0.000 sig |
| PRIMARY Burden of Clotting Factor Treatment Score |
13.55 | 0.000 sig |
| PRIMARY Impact of Clotting Factor Treatment Score |
20.15 | 0.000 sig |
| PRIMARY Risk Associated With Clotting Factor Treatment Score |
21.40 | 0.001 sig |
| PRIMARY Overall Satisfaction Score With Refacto AF FuseNGO |
93.90 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male adults (aged 18 to 65 years) with Haemophilia A (all severity levels) who currently use FVIII treatment either prophylactically or on-demand using traditional factor VIII delivery mechanisms.
- Patients advised for any reason by their physician to switch to a new factor VIII delivery device, namely FuseNGO, before receiving any details about this study or Patients who requested to be treated with a new factor VIII delivery device namely FuseNGO, before receiving any details about this study.
Exclusion Criteria
- Patients not previously recommended by their physician to switch to this new factor VIII delivery system or Patients who did not previously ask their physician to be switched to this new factor VIII delivery system.
- Patients for which it is anticipated that 10 infusions will not occur in the 12 months following their inclusion in the study.
Data sourced from ClinicalTrials.gov (NCT01959919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.