Status:
COMPLETED
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
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 trea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00932555
Start Date
April 1 2009
End Date
December 1 2011
Last Update
March 14 2012
Active Locations (1)
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1
Many Locations, Taiwan