This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of SCT800 in long term prophylaxis and on-demand treatment in patients 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 V1, on-demand treatment is given when bleeding episodes occur. The study period is 120 consecutive weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Participants received SCT800 for prophylaxis and/or on-demand treatment for 120 weeks.
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
RECRUITINGIncidence of FVIII inhibitors
The Nijmegen-Bethesda assay shall be used to monitor the production of FVIII inhibitors during the trial.
Time frame: up to 120 weeks
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 120 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: up to 120 weeks
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 120 weeks
Feng Xu
CONTACT
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