Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.
TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGPharmacokinetic assessment, based on plasma concentration of Recombinant Human Coagulation Factor VIIa.
Time frame: pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of activated partial thromboplastin time (APTT).
Time frame: pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of prothrombin time (PT).
Time frame: pre-dosing on Day 1 up to 24 hours post-dosing
Immunogenicity assessment, based on inhibitors to Factor VIIa (FVIIa) or Factor VIII (FVIII) or Factor IX (FIX).
Time frame: through study completion,an average of 1year.
Adverse events
Time frame: The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study.
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