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:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06137092
Eligibility Criteria:
Inclusion Criteria:
* Male patients ≥ 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
* Diagnosed with severe hemophilia A (endogenous FVIII \<1% \[1 IU/dL\])
* History of at least 150 documented prior exposure days to any FVIII product
* Having adequate bone marrow and organ function:
* Plt ≥ 80,000 cells/µL
* Hb ≥ 8 mg/dL
* eGFR ≥ 30 mL/min
* ALT or AST ≤ 5×ULN
* Serum bilirubin ≤ 1.5×ULN
Exclusion Criteria:
* Measurable anti-drug antibody activity against FVIII (≥ 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
* History of other coagulation disorders except for hemophilia A
* Acute hemorrhagic state
* Infection with HCV or HBV
* HIV-positive patients
* Infusion of any products containing FVIII within 7 days prior to first administration
* Previous treatment with commercially available extended half-life FVIII products
* Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
* Current systemic treatment with immunosuppressive drugs
* Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIG)
* Planned elective surgery
* Current enrolment or willing to enroll in any other experimental study during the time of current trial
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Study:
NCT06137092
Study Brief:
Protocol Section:
NCT06137092