Study of Nuwiq Recombinant Factor VIII With Emicizumab to Prevent Bleeding in Males Over 12 With Severe Hemophilia A Undergoing Major Surgery

What this Trial Is About

This research aims to evaluate the overall perioperative haemostatic effectiveness of Nuwiq, a recombinant factor VIII, combined with emicizumab prophylaxis in male patients aged 12 and older with severe haemophilia A undergoing major surgery. The study is a prospective, open-label, multinational, multicentre, single-arm trial focused on patients receiving emicizumab who require additional FVIII during surgery. Participants will receive Nuwiq intravenously following the approved prescribing information. Treatment will be administered every 8 to 24 hours as needed until adequate wound healing is achieved. If necessary, treatment may continue for at least another 7 days to maintain factor VIII plasma levels between 30 and 60 IUdL. This regimen aims to provide effective haemostatic cover throughout the surgical and healing period. Throughout the study, participants will be monitored during surgery and until wound healing is complete, typically within 30 days after surgery. Assessments include measuring haemostatic efficacy during and after surgery, blood product transfusion levels, factor VIII plasma levels, thrombin generation, and monitoring for thrombotic events, inhibitor formation, and adverse events. The study duration covers the surgical procedure and a follow-up period to ensure safety and treatment response.

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study