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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT02078427
Eligibility Criteria:
Inclusion Criteria:
* Participant has hemophilia A {FVIII lesser than or equal to (\<=)5%}
* Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
* Participant or participant's legally authorized representative provides informed consent
Exclusion Criteria:
* Participant has known hypersensitivity to the active substance or any of the excipients
* Participant has known allergic reaction to mouse or hamster proteins
* Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02078427
Study Brief:
Protocol Section:
NCT02078427