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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04085458
Eligibility Criteria:
Inclusion Criteria:
* Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
* Participants with severe hemophilia A (FVIII: C\<1%)
* PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
* Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count \>200/mm\*3
* Participants who are willing to complete an eDiary
* Male participants
* Capable of giving signed informed consent
Exclusion Criteria:
* Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
* Platelet count \< 100,000/mm\*3
* Creatinine \> 2x upper limit of normal
* AST or ALT \> 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
* The participant has a planned major surgery.
* The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
* Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
* Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04085458
Study Brief:
Protocol Section:
NCT04085458