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Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Details
| Lead sponsor | Octapharma |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 28 |
| Start date | 2026-04 |
| Completion | 2027-02 |
Conditions
- 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, Finland, France, Germany, Italy, Serbia, Spain, Switzerland, United Kingdom, Uruguay