Hemophilia A Clinical Trial
Official title:
A Multicenter, Open, Single Arm Evaluation of the Efficacy, Safety and Pharmacokinetics of Recombinant Human Coagulation FVIII (SCT800) in Prophylaxis Therapy on Patients With Severe Hemophilia A Who Had Previously Treated With FVIII.
This study is a multi-center, open-label, single-arm 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:C) . 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 and prophylaxis with SCT800 shall continue for 24 consecutive weeks.
After subjects pass screening, prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered
once every other day or three times per week for 6 months. Subjects shall receive FVIII
intravenous injection treatment at the study site or at home. During the study prophylaxis
treatment period, subjects should return for visit every four weeks, namely for Visit (V) 2
(4 weeks ± 4 days), Visit 3 (8 weeks ± 4 days), Visit 4 (12 weeks ± 4 days), Visit 5 (16
weeks ± 7 days), Visit 6 (20 weeks ± 7 days), Visit 7 (24 weeks ± 7 days) and
end-of-treatment (EOT) visit (+ 14 days). Of which, blood collection shall be carried out
during the screening period and in V1, V2, V4, V7 and the EOT visit for FVIII inhibitor
assay; blood collection shall be carried out before and after the completion of SCT800
infusion in V1, V4 and V7 for incremental in-vivo recovery (IVR) assay.
FVIII:C activity shall be monitored before injection and 15minutes(min), 30min, 1h, 3h, 6h,
9h, 12h, 24hours(h), 28h, 32h and 48h after injection at V1 and V7. Then pharmacokinetics
parameters (incremental in-vivo recovery, t1/2 etc.) of SCT800 shall be calculated and
evaluated.
5 subjects may receive elective surgical treatment within the prophylaxis treatment period
(after the first drug administration in day 0).
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