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Clinical Trials associated with Recombinant human coagulation factor IX, FC Fusion protein(CSL Behring GmbH)一项在既往接受过治疗的中国B型血友病受试者中评估重组人凝血因子IX-白蛋白融合蛋白(rIX-FP)的药代动力学、疗效和安全性的III期、开放性、多中心研究
[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%).
100 Clinical Results associated with Recombinant human coagulation factor IX, FC Fusion protein(CSL Behring GmbH)
100 Translational Medicine associated with Recombinant human coagulation factor IX, FC Fusion protein(CSL Behring GmbH)
100 Patents (Medical) associated with Recombinant human coagulation factor IX, FC Fusion protein(CSL Behring GmbH)
100 Deals associated with Recombinant human coagulation factor IX, FC Fusion protein(CSL Behring GmbH)