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Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.

RecruitingPhase 3Ages any - 6 YearsMaleSinocelltech Ltd.
NCT07437404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • SCT800 prophylaxis and treatment for bleeding events
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Where

1 site
Beijing children's hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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