ADVATE/ ADYNOVI Hemophilia A Outcome Database

061001

The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

2011-06-28

2024-01-16

2024-01-16

Completed

955

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 955, 'type': 'ACTUAL'}}

2024-01-25