[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the pharmacokinetic characteristics of human fibrinogen in patients with congenital fibrinogen deficiency, as well as the safety and efficacy of human fibrinogen in the treatment of bleeding events
主要目的:
1. 评价蜀阳人纤维蛋白原在先天性纤维蛋白原缺乏症患者中单次用药的药代动力学特征;
2. 评价蜀阳人纤维蛋白原治疗先天性纤维蛋白原缺乏症患者出血事件的有效性。
次要目的:
1. 评价蜀阳人纤维蛋白原治疗先天性纤维蛋白原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缺乏症患者中单次用药的药代动力学特征。
[Translation] Main objectives:
1. To evaluate the pharmacokinetic characteristics of Shuyang human fibrinogen in patients with congenital fibrinogen deficiency after a single dose;
2. To evaluate the effectiveness of Shuyang human fibrinogen in treating bleeding events in patients with congenital fibrinogen deficiency.
Secondary objectives:
1. To evaluate the safety of Shuyang human fibrinogen in treating bleeding events in patients with congenital fibrinogen deficiency;
2. To evaluate the pharmacokinetic characteristics of similar products on the market after a single dose in patients with congenital fibrinogen deficiency.