SCT800 for Preventing and Treating Bleeding in Young Children With Severe Hemophilia A
Tests SCT800 in children with severe hemophilia A who have not been treated before.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Children's HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sinocelltech Ltd.
- Trial code
- NCT07437404
- Record updated
- 27 February 2026
- Original description
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.Read full original descriptionShow less
An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
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.
Inclusion: 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: 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; Patients with other coagulation dysfunction diseases in addition to hemophilia A; Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN; International Normalized Ratio (INR) > 1.5.