Brief Title
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Official Title
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
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.
Study Type
Observational
Primary Outcome
Efficacy and Safety of Kogenate FS
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
82
Start Date
April 2009
Completion Date
December 2011
Eligibility Criteria
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.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT00932555
Organization ID
14344
Secondary IDs
KG0803
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
March 2012