Blood Coagulation Disorders, Hemophilia A
Conditions
Keywords
Octocog alfa, Hemophilia A
Brief summary
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.
Interventions
Patients under daily life treatment receiving Kogenate according to local drug information.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total consumption of FVIII | After 12 months and after 24 months |
| Number of bleedings | After 12 months and after 24 months |
| Kind of bleedings | After 12 months and after 24 months |
| Continuation of therapy | After 12 months and after 24 months |
| Overall assessment by the physician | After 12 months and after 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event collection | After 12 months and after 24 months |
Countries
Mexico, Venezuela
Outcome results
None listed