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Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Details
| Lead sponsor | Octapharma |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 28 |
| Start date | 2023-11-28 |
| Completion | 2026-09 |
Conditions
- Severe Hemophilia A
Interventions
- Nuwiq
Primary outcomes
- Overall haemostatic efficacy — During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure
Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure.
Countries
United States, Croatia, Finland, France, Germany, India, Italy, North Macedonia, Serbia, Spain, United Kingdom