Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Xiangya Hospital of Centre-South University
Changsha, Hunan, China
Incremental Recovery (K-value)
One-stage aPTT Assay
Time frame: 1hour after the end of the infusion
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
Elimination Phase Half-life (t1/2)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
Factor VIII (FVIII) Clearance (CL)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
FVIII Maximum Plasma Concentration (Cmax)
One-stage aPTT Assay
Time frame: 3 hours after the end of the infusion
Mean Residence Time (MRT)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
Volume of Distribution at Steady State (Vss)
One-stage aPTT Assay
Time frame: 48 hours after the end of the infusion
Incidence of inhibitors
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Time frame: 72 hours after the end of the infusion
AEs related to SCT800 during treatment and observation of the clinical study
Time frame: 48 hours after the end of the infusion