Overview
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.
Description
SCT800 is a recombinant human coagulation factor VIII, which was on market in 2021 in China. The indication of SCT800 is prophylaxis and control of bleeding events in adult and children, and for the perioperative management of bleeding events. This study continued to evaluate the safety and efficacy of SCT800 in previously untreated patients with severe haemophilia A.
Eligibility
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.
