EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Completed
- Conditions
- Hemophilia A
- Registration Number
- NCT00874926
- Lead Sponsor
- Bayer
- Brief Summary
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 405
Inclusion Criteria
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/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.
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the local product information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Safety of Kogenate Bayer/FS After 12 months, after 24 months
- Secondary Outcome Measures
Name Time Method