Additional Relevant Details
The prospective, uncontrolled, open-label, nonrandomized, international, multi-center Phase 3 study enrolled 15 patients 18 years and older diagnosed with severe congenital VWD undergoing major and minor elective surgical procedures. The study assessed the safety and hemostatic efficacy of VONVENDI used before, during or after a surgical procedure, with or without, a recombinant Factor VIII (rFVIII) treatment. Overall hemostatic efficacy was rated as “excellent” or “good” for all 15 treated subjects. A total of 12 treatment emergent adverse events (TEAEs) occurred in six patients during or after infusion treatment. Two serious TEAEs occurred in two patients. Ten non-serious TEAEs occurred in six patients. None of the TEAEs that occurred during the study were assessed as severe allergic reaction. In addition, none of the study subjects developed inhibitory antibodies to VONVENDI, rFVIII or binding antibodies to CHO, rFurin or murine IgG.2