Patients: 13 male patients aged 13–70 with hemophilia B and FIX activity ≤0.02 IU/mL who were scheduled for major surgery. Patients had at least 150 prior exposure days to standard FIX products and no history of FIX inhibitors.
Study design: On the day of their respective surgeries, patients received 1 infusion of Rebinyn® 80 IU/kg. Postoperatively, subjects received infusions of Rebinyn® 40 IU/kg at the investigator’s discretion for up to 3 weeks after surgery. Across 13 surgical procedures—which included 9 orthopedic, 1 gastrointestinal, and 3 oral cavity procedures—the hemostatic effect during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good hemostasis. Mean FIX activity following an initial preoperative Rebinyn® 80 IU/kg dose in 13 procedures was assessed by one-stage assay with product-specific standard.1,4
Primary endpoint: Intraoperative hemostatic effect during and after surgery, measured by the investigator or surgeon according to a four-point response scale: excellent, good, moderate, or poor.
Secondary endpoint: Efficacy of Rebinyn®, as measured by hemoglobin levels, Rebinyn® consumption, and number of doses per procedure.