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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01458106
Eligibility Criteria:
Key Inclusion Criteria:
* Severe hemophilia A defined as \<1 IU/dL (\<1%) endogenous FVIII
* Male \<12 years of age and weight ≥13 kg
* History of at least 50 documented prior exposure days to FVIII
* No current, or history of, inhibitor development to FVIII
Key Exclusion Criteria:
* Other coagulation disorders in addition to Hemophilia A
* History of anaphylaxis associated with any FVIII or IV immunoglobulin administration
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
11 Years
Study:
NCT01458106
Study Brief:
Protocol Section:
NCT01458106