Human Fibrinogen(Tonrol Biological Pharmaceutical)

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 efficacy and safety of human fibrinogen in the treatment of hypofibrinogenemia and provide clinical basis for registration.