N/A
Completed N=135
ADYNOVATE Drug Use-Results Survey
Source: ClinicalTrials.gov NCT03169972 ↗Enrolled (actual)
135
Serious AEs
2.2%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants Who Discontinued the Use of Study Drug — 10; 5 Participants
Summary
The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:
1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and efficacy
4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Discontinued the Use of Study Drug |
10; 5 | — |
| PRIMARY Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen |
1.99 | — |
| PRIMARY Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen |
3.16; 2.91 | — |
| PRIMARY Duration of Treatment of Study Drug on a Prophylaxis Regimen |
343.0; 510.7 | — |
| PRIMARY Duration of Treatment of Study Drug an On-Demand Regimen |
13.3; 5.0 | — |
| PRIMARY Dose Per Administration of Study Drug on a Prophylaxis Regimen |
39.4; 45.8 | — |
| PRIMARY Dose Per Administration of Study Drug an On-Demand Regimen |
36.8; 29.7 | — |
| PRIMARY Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen |
6.0; 5.0 | — |
| PRIMARY Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen |
37.21; 20.00; 62.79; 40.00; 0.00; 0.00 | — |
| PRIMARY Hemostatic Effectiveness of Study Drug on an On-Demand Regimen |
32.76; 33.33; 60.34; 33.33; 6.90; 0.00 | — |
| SECONDARY Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen |
2.0; 1.8 | — |
| SECONDARY Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE) |
1; 3; 0; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.
Exclusion Criteria
- Patients not administered ADYNOVATE.
Data sourced from ClinicalTrials.gov (NCT03169972). 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.