Nuwiq Dosing for Women/Girls with Hemophilia A Undergoing Surgery
This study is looking at how well Nuwiq works for women and girls with hemophilia A (a bleeding disorder where blood doesn't clot properly) who are having major surgery. Nuwiq is a treatment that helps blood clot. The study wants to see if Nuwiq can effectively prevent bleeding during and after surgery. You might be able to join if you are a woman or girl aged 12 or older with hemophilia A who needs FVIII treatment for surgery. The study will measure how well Nuwiq controls bleeding during surgery and until your wound heals, which is about 30 days after the surgery. The current status of this study is unclear, and it plans to enroll 28 participants.
- Study design
- This is a single-arm, open-label study, meaning all 28 participants will receive Nuwiq, and both you and the study team will know what treatment you are getting.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your bleeding will be monitored during surgery and until your wound has completely healed, which is about 30 days after the surgical procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
At a glance
Conditions
Where it's being run
16 sites across 10 statesStudy leadership
- Johannes Oldenburg · PRINCIPAL_INVESTIGATOR · Experimental Haematology and Transfusion Medicine, University Clinic Bonn
Who to contact
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What this trial measures
- Overall haemostatic efficacyDuring 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.