7- and 14-day prophylaxis*
*Data based on matched-pairs design. †IQR is the middle 50% of people in a clinical study.
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 an additional median duration of 10 months.
‡After administration of a single infusion of IDELVION. § Data from the phase I trial, a first-in-human prospective, multicenter, open-label dose-escalation study to evaluate the safety and PK of 25, 50, and 75 IU/kg rIX-FP in subjects with hemophilia B. Twenty-five subjects were enrolled in order to ensure at least 13 evaluable subjects in the 50 IU/kg dosing group, and at least 4 evaluable subjects in both the 25 and 75 IU/kg rIX-FP dosing groups. All subjects received rIX-FP in a non-bleeding state and after a washout period of at least 4 days from their last dose of the previous FIX product.2
Patient population included:
‖ In 3 clinical studies, 13 subjects received IDELVION for perioperative management of 15 surgical procedures.
“Before my surgery we discussed the right IDELVION dosage options. Doing what I could to control the outcome and improve results felt good.”Watch Tony’s full story
References: 1. Santagostino E, Martinowitz U, Lissitchkov T, et al. Long acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016;127(14):1761-1769. 2. Santagostino E, Negrier C, Klamroth R, et al. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012;120(12):2405-2411. 3. Négrier C, Karim FA, Lepatan LM, et al. Efficacy and safety of long-acting recombinant fusion protein linking factor IX with albumin in haemophilia B patients undergoing surgery. Haemophilia. 2016;22(4):e259-e266. 4. Gill JC, Roberts J, Li Y, Castaman G. Sustained high trough factor IX activity levels with continued use of rIX-FP in adult and paediatric patients with haemophilia B. Haemophilia. 2019. doi:10.1111/hae.13735.