This study is a multicenter phase III uncontrolled open-label trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (\<12 years old) with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from Visit 1 and prophylaxis with SCT800 shall continue for 24 consecutive weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
70
Participant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
Annualized Bleeding Rate
Annualized Bleeding Rate(ABR) can be calculated using the following formula: Number of bleeding events in efficacy evaluation period/(number of days in treatment period/365.25)
Time frame: up to 24 weeks
Annualized joint bleeding rate
Annualized joint bleeding rate(AJBR) can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25).
Time frame: up to 24 weeks
FVIII incremental in-vivo recovery
Incremental recovery is determined as the peak factor level recorded in the first hour after infusion and is reported as \[IU/ml\]/\[IU/kg\]
Time frame: Predose within 30 min,15 min±2 min
Bleeding event treatment efficacy
The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved).
Time frame: up to 24 weeks
Elimination Half Life
t1/2; Chromogenic Assay
Time frame: Predose within 30 min,15 min±2 min、1 hour±5 min,10 hours±30 min,24 hours±1hours and 48 hours±2 hours post-dose
Clearance
CL; Chromogenic Assay
Time frame: Predose within 30 min,15 min±2 min、1 hour±5 min,10 hours±30 min,24 hours±1hours and 48 hours±2 hours post-dose
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