[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetics of human coagulation factor IX in the treatment of moderate to severe hemophilia B
主要目的:评价人凝血因子Ⅸ按需替代治疗中重型血友病B的有效性和安全性;次要目的:观察人凝血因子Ⅸ在中重型血友病B患者中单次给药后的药代动力学特征,并计算药代动力学参数。
[Translation] The primary objective is to evaluate the efficacy and safety of on-demand replacement therapy of human coagulation factor IX in patients with moderate to severe hemophilia B. The secondary objective is to observe the pharmacokinetic characteristics of human coagulation factor IX after a single dose in patients with moderate to severe hemophilia B and calculate the pharmacokinetic parameters.