Hereditary/Acquired Bleeding Disorders

PERSEPT 3: A Phase 3 Clinical Trial to Evaluate the Haemostatic Efficacy of Eptacog Beta (Recombinant Human FVIIa) in Perioperative Care in Subjects With Haemophilia A or B With Inhibitors

Patients with hemophilia type A or B with inhibitors (PwHABI) who undergo surgery must receive bypassing agents (BPA) and are at high risk of complications. In the small phase 3 PERCEPT 3 trial, the new bypassing agent eptacog beta, a human recombinant factor VIIa, was evaluated at a dose of 200 µg/kg for major procedures and 75 µg/kg for minor procedures. The agent was administered immediately prior to the initial surgical incision, with 75 µg/kg doses administered subsequently to achieve postoperative hemostasis and wound healing. The therapies were well-tolerated and, based on surgeon/investigator assessments, the majority of procedures were successful, leading the authors to conclude that "eptacog beta offers clinicians a new potential therapeutic option for procedures in PwHABI."

Haemophilia