Actively Recruiting
Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
Led by Sinocelltech Ltd. · Updated on 2026-02-27
36
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects with severe hemophilia A (FVIII:C < 1% in central laboratory tests)
- Previously untreated with plasma-derived or recombinant FVIII, including SCT800 (up to 5 exposure days to blood products like cryoprecipitate or fresh frozen plasma allowed)
- FVIII inhibitor negative
- Provided informed consent
You will not qualify if you...
- Known allergy to recombinant factor VIII concentrate or any excipient, or to bovine, rodent, or hamster proteins
- History or family history of FVIII inhibitor development
- Liver function tests (ALT, AST) 5 times or more above the upper limit of normal
- Kidney function tests (BUN, creatinine) 2 times or more above the upper limit of normal
- Other coagulation disorders besides hemophilia A
- International Normalized Ratio (INR) greater than 1.5
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing children's hospital
Beijing, Beijing Municipality, China, 000000
Actively Recruiting
Research Team
R
Runhui Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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