[Translation] A single-arm, open-label, multicenter clinical trial to evaluate the pharmacokinetics, efficacy, and safety of human fibrinogen in adults and adolescents with congenital fibrinogen reduction or deficiency.
1) 通过单次给药的PK研究,评估人纤维蛋白原在先天性纤维蛋白原减少或缺乏症患者中的药代动力学(PK)特征; 2) 观察人纤维蛋白原治疗先天性纤维蛋白原减少或缺乏症患者的有效性和安全性; 3) 通过单次给药的PK研究,评估市售人纤维蛋白原的药代动力学(PK) 特征,为获得性低纤维蛋白原血症的对照药用量计算提供依据。
[Translation] 1) Assess the pharmacokinetic (PK) characteristics of human fibrinogen in patients with congenital fibrinogen reduction or deficiency through a single-dose PK study; 2) Observe the efficacy of human fibrinogen in the treatment of congenital fibrinogen Efficacy and safety in patients with hypofibrinogen reduction or deficiency; 3) Evaluate the pharmacokinetic (PK) characteristics of commercially available human fibrinogen through a single-dose PK study for acquired hypofibrinogenemia Provide a basis for calculating the dosage of the control drug.