Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Sinocelltech Ltd.
36 participants
Apr 26, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07437404