SCT800 prophylaxis and treatment for bleeding events
SCT800 prophylaxis and treatment for bleeding events: For prophylaxis, 15-50 IU/kg SCT800 is intravenously. For control of bleeding events(BE), 10-20 IU/kg for mild BE, 15 -30IU/kg for moderate BE, 30-50IU/kg for severe BE.
Study summary
This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Eligibility
Sex
MALE
Min age
—
Max age
6 Years
Healthy volunteers
No
Inclusion Criteria:
* Male subjects with severe hemophilia A (FVIII:C \< 1% in central laboratory tests)
* previously untreated with pdFVIII/rFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).
* FVIII inhibitor negative
* informed consent.
Exclusion Criteria:
* Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
* subjects with a history or family history of FVIII inhibitor formation;
* Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;
* Patients with other coagulation dysfunction diseases in addition to hemophilia A.
* International Normalized Ratio (INR) \> 1.5.
Primary outcome measure(s)
Incidence of FVIII inhibitor — up to 50-100 Exposure Days The percentage of FVIII inhibitor measured by Nijmegen-Bethesda
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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