*Data based on a matched-pairs design.
Phase II/III study design: The safety and efficacy of IDELVION were evaluated in a prospective, open-label, multicenter clinical study of 63 male PTPs with hemophilia B (≤2% endogenous FIX activity) who received at least one infusion of IDELVION. Subjects were aged 12 to 61 years; including 7 adolescent subjects aged 12 to 17. Subjects were treated for up to 27 months.
Forty subjects received weekly routine prophylaxis. Thirty-seven subjects completed 6 months of once-weekly prophylaxis. Of these, 21 subjects switched to a 14-day interval with 50–75 IU/kg of IDELVION.
Twenty-three subjects received IDELVION only for the treatment of bleeding episodes during the first 6 months of the study. Nineteen switched to once-weekly prophylaxis with additional median duration of 10 months.
7- and 14-DAY PROPHYLAXIS*
†In three clinical studies, 13 subjects received IDELVION for perioperative management of 15 surgical procedures. The 15 surgical procedures included a double mastectomy, four knee replacements, a hemorrhoidectomy, a rhinoplasty, a nevus excision, an ankle arthroplasty, an endoscopic mucosal resection, four complicated dental surgeries and one uncomplicated dental surgery. Two of the four dental surgeries were performed in children <12 years of age.