Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117. Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.
People'S Hospital of Zhengzhou
Zhengzhou, Henan, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
People'S Hospital of Rizhao
Rizhao, Shandong, China
Maximum measured concentration of FVIII:C (Cmax)
Measured by One-Stage Clotting Assay
Time frame: Pre-dose and post dose up to 10 days
Time required for the concentration of the drug to reach half of its original value (T1/2)
Measured by One-Stage Clotting Assay
Time frame: Pre-dose and post dose up to 10 days
Area Under the Curve to Infinity (AUC)
Measured by One-Stage Clotting Assay
Time frame: Pre-dose and post dose up to 10 days
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL)
Measured by One-Stage Clotting Assay
Time frame: Pre-dose and post dose up to 10 days
Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants
Time frame: Pre-dose and post dose up to 36 days
Evaluation of the level of anti-PEG antibody production in participants
Time frame: Pre-dose and post dose up to 36 days
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.
Time frame: Pre-dose and post dose up to 36 days
Development of Inhibitor
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Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Tianjin, Tianjin Municipality, China
Measured by the Nijmegen-Modified Bethesda Assay
Time frame: Pre-dose and post dose up to 36 days
score of bleeding symptoms and Vital signs
Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale
Time frame: Pre-dose and post dose up to 36 days