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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03947567
Eligibility Criteria:
Inclusion Criteria:
* Male patients who are diagnosed with severe (laboratory tested FVIII:C \<2%) hemophilia A;
* Patients Who Completed trial of SCT800-A302 or SCT800-A 303 and New PTP(previously treated patients)(Previously received FVIII prophylactic or bleeding treatment, have the relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
* Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay result \<0.6 BU(Bethesda unit)/mL);
* The treatment records of at least 50EDs before screening can be obtained;
* HIV negative; if HIV positive, the viral load \<200 particles/uL or \<400,000 copies/mL, and HIV patients must satisfy CD4+ count \>200/μL;
* The patient or his guardian voluntarily signed the Informed Consent Form.
Exclusion Criteria:
* Known allergy to any coagulation factor VIII or any excipient; known allergy to bovine, rodent or hamster bovine;
* Has a history or family history of blood coagulation factor VIII inhibitor;
* Patients with other coagulation dysfunction diseases in addition to hemophilia A;
* Patients with other clinically significant diseases, alcoholism, drug abuse, mental disorders or intellectual disabilities;
* Patients with other severe or clinical significant diseases verified by the investigator to be unable to benefit from the clinical study;
* Patients who participated in other clinical studies within one month before the first drug administration (except FVIII trials) and patients who participated in other FVIII clinical trials after signing the Informed Consent Form;
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT03947567
Study Brief:
Protocol Section:
NCT03947567