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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03815318
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥12 years old and ≤65 years old;
* Male patients who are clinically diagnosed with severe (laboratory tested FVIII:C \<1%) hemophilia A, including historical FVIII:C \<1%;
* Previously received FVIII treatment (prophylactic or bleeding treatment), have the relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
* The bleeding treatment records of at least 3 months before screening can be obtained;
* Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay result \<0.6 BU(Bethesda unit)/mL);
* The prothrombin time is normal or international normalized ratio (INR) ≤1.5; 7. Platelet count ≥100 × 109/L;
Exclusion Criteria:
* Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
* Has a history or family history of blood coagulation factor VIII inhibitor;
* Clinical liver function test (glutamic-pyruvic transaminase, glutamic-pyruvic transaminase) ≥ three times the upper limit of normal (ULN) or clinical kidney function test (blood urea nitrogen, creatinine) ≥ three times the ULN;
* Patients clinically diagnosed with active Hepatitis B or Hepatitis C;
* Patients with other coagulation dysfunction diseases in addition to hemophilia A;
* Patients with severe heart disease, including myocardial infarction and cardiac dysfunction of class III or above;
* Patients who previously experienced intracranial bleeding;
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT03815318
Study Brief:
Protocol Section:
NCT03815318