In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A. These subjects will receive open label treatment with SCT800 for approximately 6 months for on-demand treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
recombinant human coagulation factor VIII
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
Haemostatic effect of SCT800 evaluated according to a predefined four grade scale: excellent, good, moderate, or no response
Time frame: Up to 6 months
The incidence rate of FVIII inhibitors (≥0.6 BU)
Time frame: Up to 6 months
The number of infusions of SCT800 required per bleeding episode
Time frame: Up to 6 months
Actual consumption of SCT800 (IU/Kg/bleed)
Time frame: Up to 6 months
AEs related to SCT800 during the clinical study
Time frame: Up to 6 months
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