[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetic characteristics of human coagulation factor VIII as an on-demand treatment for bleeding events in patients with hemophilia A (factor VIII deficiency)
主要目的:
评价血友病A患者采用人凝血因子Ⅷ按需治疗出血事件的有效性,为注册申报生产提供依据。
次要目的:
1)评价血友病A患者采用人凝血因子Ⅷ按需治疗出血事件的安全性;
2)通过单次给药的药代动力学(PK)试验,评价人凝血因子Ⅷ在血友病A患者中的药代动力学特征。
[Translation] Main purpose:
To evaluate the effectiveness of human coagulation factor VIII in the treatment of bleeding events in hemophilia A patients on demand, and to provide a basis for registration and production application.
Secondary purpose:
1) To evaluate the safety of human coagulation factor VIII in the treatment of bleeding events in hemophilia A patients on demand;
2) To evaluate the pharmacokinetic characteristics of human coagulation factor VIII in hemophilia A patients through a single-dose pharmacokinetic (PK) test.