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Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
Sponsor: Sinocelltech Ltd.
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.
Official title: An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Key Details
Gender
MALE
Age Range
Any - 6 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-04-26
Completion Date
2028-12-26
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
SCT800 prophylaxis and treatment for bleeding events
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)
Beijing children's hospital
Beijing, Beijing Municipality, China