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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01810666
Eligibility Criteria:
Inclusion Criteria:
* Male, aged 2-16yrs
* Severe hemophilia A (\<1% FVIII:C \[Blood Clotting Factor VIII:C\] )
* Minimum of at least 50 documented ED (exposure day) prior to enrolment
* No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
* Parents or legal guardians document, sign, and date informed consent
Exclusion Criteria:
* Another bleeding disease that is different from hemophilia A
* Known hypersensitivity to the active substance, mouse or hamster protein
* Thrombocytopenia (platelet count \<100 000/mm3) based on previous medical records
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT01810666
Study Brief:
Protocol Section:
NCT01810666