Kogenate FS regulatory Post-Marketing Surveillance (KG0910KR)
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.
The observation period for each patient is up to 6 months.
- Patients with diagnosis of hemophilia A - Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS - Signed the informed consent form to participate in this study. - For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available - For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available - For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA - Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.
- Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
Many locations, South Korea
E-mail: [email protected]
Phone: Not Available
KOGENATE® FS , Local Post Authorization Safety Study