[Translation] A Phase III, open-label, multicenter study to evaluate the pharmacokinetics, efficacy, and safety of recombinant human factor IX-albumin fusion protein (rIX-FP) in previously treated Chinese subjects with hemophilia B
主要目的:在单次给药PK阶段评价50 IU/kg rIX-FP在既往接受过治疗的中国B型血友病患者(FIX活性≤2%)中的PK;在既往接受过治疗的中国B型血友病患者(FIX活性≤2%)中评价rIX-FP常规预防治疗给药预防自发性出血事件的疗效;在既往接受过治疗的中国B型血友病患者(FIX活性≤2%)中评价rIX-FP常规预防治疗给药在FIX抑制物形成方面的安全性。
[Translation] Primary objectives: To evaluate the PK of 50 IU/kg rIX-FP in previously treated Chinese patients with hemophilia B (FIX activity ≤2%) in the single-dose PK phase; to evaluate the efficacy of routine prophylactic administration of rIX-FP in preventing spontaneous bleeding events in previously treated Chinese patients with hemophilia B (FIX activity ≤2%); to evaluate the safety of routine prophylactic administration of rIX-FP in the formation of FIX inhibitors in previously treated Chinese patients with hemophilia B (FIX activity ≤2%).