Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07437404
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
6 Years
Study:
NCT07437404
Study Brief:
Protocol Section:
NCT07437404