PHASE I/II STUDY IN PREVIOUSLY TREATED SEVERE HEMOPHILIA B

该研究的主要目的是评估其安全性和有效性。 在既往接受治疗的患者中，重组人纤维细胞生长因子。次要目标是 估计药物动力学参数，包括回收率和半衰期， 静脉滴注重组人纤维细胞生长因子，以评估 重组人FIX与混合人血浆的药代动力学参数比较 莫诺宁用于评价重组人纤维细胞生长因子治疗的疗效和安全性 急性出血事件及评价重组人纤维细胞生长因子的有效性和安全性 在控制手术中和手术后出血方面的作用。

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.