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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02392156
Eligibility Criteria:
Key Inclusion Criteria:
* Have a medically documented diagnosis of hemophilia A or B that is being treated prophylactically with a factor replacement product not designed to have a prolonged half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved local label
* Have at least 50 prior exposure days (EDs) to any combination of factor replacement products
* Have documented pre-study data available that confirm fulfillment of the eligibility criteria
* Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the Baseline visit, and absence of clinical signs or symptoms of decreased response to the current factor replacement product
Key Exclusion Criteria:
* Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B
* Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX (FIX) or intravenous immunoglobin administration
* Had an inhibitor within 5 years before the Baseline visit. Note: A family history of inhibitors will not exclude the patient.
* Past or current treatment with any factor replacement product with a prolonged half-life, including an Fc product, for the treatment of hemophilia
NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02392156
Study Brief:
Protocol Section:
NCT02392156