Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection at two dose levels in patients with hemophilia A. Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in patients with hemophilia A.
Study Type
OBSERVATIONAL
Enrollment
12
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangzhou, China
Jinan Central Hospital
Jinan, Shandong, China
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Maximum measured concentration of FVIII:C (Cmax).
Measured by the One-stage aPTT Clotting Assay.
Time frame: Pre-dose and post dose of FRSW107 up to 10 days.
Time required for the concentration of the drug to reach half of its original value (T1/2).
Measured by the One-stage aPTT Clotting Assay.
Time frame: Pre-dose and post dose of FRSW107 up to 10 days.
Area Under the Curve to Infinity (AUC).
Measured by the One-stage aPTT Clotting Assay.
Time frame: Pre-dose and post dose of FRSW107 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 the One-stage aPTT Clotting Assay.
Time frame: Pre-dose and post dose of FRSW107 up to 10 days.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.
Time frame: Post dose of FRSW107 up to 28.
Development of Inhibitor.
Measured by the Nijmegen-Modified Bethesda Assay.
Time frame: Pre-dose and post dose of FRSW107 up to 28 days.
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Hematology Department, Beijing Children's Hospital, Capital Medical University
Beijing, China