Status:
COMPLETED
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Lead Sponsor:
Bayer
Conditions:
Blood Coagulation Disorders
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 :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00969319
Start Date
September 1 2009
End Date
February 1 2014
Last Update
January 19 2015
Active Locations (2)
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1
Many Locations, Mexico
2
Many Locations, Venezuela