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

Recruiting now · Phase 3

Conditions studied: Haemophilia A

In brief

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.

Key facts

Study ID

NCT07437404

Run by

Sinocelltech Ltd.

People needed

36

Starts

2024-04-26

Expected to finish

2028-12-26

Last updated by the study team

2026-02-27

Who can join

Age: any, up to 6. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beijing children's hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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