PHASE I/II STUDY IN PREVIOUSLY TREATED SEVERE HEMOPHILIA B

本研究的主要目的是评估安全性和有效性 rhFIX在既往接受过治疗的患者中的作用。 次要目的是 估计药代动力学参数，包括回收率和半衰期， 静脉输注rhFIX，以评价 与合并人血浆相比，rhFIX的药代动力学参数 评价rhFIX在治疗中的有效性和安全性 急性出血事件，并评价rhFIX的疗效和安全性 控制手术过程中和手术后的出血。

The primary objectives of the study are to assess the safety and efficacy of rhFIX in previously treated patients. Secondary objectives are to estimate the pharmacokinetic parameters, including recovery and half-life, of rhFIX administered as an intravenous infusion, to evaluate the pharmacokinetic parameters of rhFIX in comparison to pooled human plasma product Mononine to evaluate the efficacy and safety of rhFIX in treating acute bleeding episodes and to evaluate the efficacy and safety of rhFIX in controlling bleeding during and after surgical procedures.