Hemophilia A
Conditions
Keywords
Kogenate FS, Hemophilia A
Brief summary
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.
Interventions
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
Sponsors
Bayer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events collection | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Type of the treatment (prophylaxis, on demand, surgery) | Initial visit and 6 month f/u or at the end of the observation visit |
| Total consumption of FVIII | Initial visit and 6 month f/u or at the end of the observation visit |
| Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively) | Initial visit, 6 month follow-up visit and 12 month follow-up visit |
| General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient | 6 month f/u or at the end of observation visit |
Countries
South Korea
Outcome results
None listed