Study of Nuwiq to Prevent Bleeding in Women and Girls Over 12 With Hemophilia A During Major Surgery

What this Trial Is About

Researchers are evaluating the use of Nuwiq, a recombinant factor VIII, to prevent bleeding in women and girls aged 12 and older with mild to moderate haemophilia A who are undergoing major surgery. This open-label, non-controlled, single-arm international study aims to assess how well Nuwiq controls bleeding during and after surgery in this specific population. All participants will receive Nuwiq administered through intravenous infusion following prescribed guidelines. The treatment will be given repeatedly every 8 to 24 hours as needed until the surgical wound shows adequate healing. If necessary, treatment will continue for at least an additional 7 days to maintain factor VIII plasma levels between 30 and 60 IUdL. Participants will be closely monitored throughout the study period, including during surgery and up to 30 days after the procedure. Researchers will assess overall haemostatic effectiveness, including during surgery and wound healing, measure factor VIII plasma levels before and after injections, and record any adverse or thrombotic events. Safety monitoring will continue from the first dose through 30 days post-surgery to ensure comprehensive evaluation of outcomes.

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery