[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the pharmacokinetic characteristics of human fibrinogen in patients with congenital fibrinogen deficiency or deficiency, as well as the safety and efficacy of human fibrinogen in the treatment of bleeding events
主要目的:(1)评价康宝人纤维蛋白原在先天性纤维蛋白原减少或缺乏症患者中单次用药的药代动力学特征;(2)评价康宝人纤维蛋白原治疗先天性纤维蛋白原减少或缺乏症患者出血事件的有效性。 次要目的:(1)评价康宝人纤维蛋白原治疗先天性纤维蛋白原减少或缺乏症患者出血事件的安全性;(2)评价已上市同类产品在先天性纤维蛋白原减少或缺乏症患者中单次用药的药代动力学特征。
[Translation] Primary objectives: (1) To evaluate the pharmacokinetic characteristics of a single dose of Conbo human fibrinogen in patients with congenital fibrinogen deficiency or deficiency; (2) To evaluate the effectiveness of Conbo human fibrinogen in treating bleeding events in patients with congenital fibrinogen deficiency or deficiency. Secondary objectives: (1) To evaluate the safety of Conbo human fibrinogen in treating bleeding events in patients with congenital fibrinogen deficiency or deficiency; (2) To evaluate the pharmacokinetic characteristics of a single dose of similar products already on the market in patients with congenital fibrinogen deficiency or deficiency.