EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE┬« FS in Taiwan
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222) (Biological)
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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
Official title: EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE« FS in Taiwan
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Efficacy and Safety of Kogenate FS
Minimum age: N/A.
Maximum age: N/A.
- 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.
Locations and Contacts
Many Locations, Taiwan
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Starting date: April 2009
Last updated: March 13, 2012