Tonrol Biological Pharmaceutical Co. Ltd.

To evaluate the safety and clinical efficacy of human fibrinogen in the treatment of acquired hypofibrinogenemia caused by chronic liver disease.

1) To evaluate the pharmacokinetic (PK) characteristics of human fibrinogen in patients with congenital fibrinogen deficiency or hypofibrinogenemia through a single-dose PK study; 2) To observe the efficacy and safety of human fibrinogen in the treatment of patients with congenital fibrinogen deficiency or hypofibrinogenemia; 3) To evaluate the pharmacokinetic (PK) characteristics of commercially available human fibrinogen through a single-dose PK study to provide a basis for the calculation of the dosage of the control drug for acquired hypofibrinogenemia.

To evaluate the safety and efficacy of human prothrombin complex therapy in the treatment of hemophilia B through a multicenter clinical trial.