EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00932555
First received: July 2, 2009
Last updated: March 13, 2012
Last verified: March 2012

July 2, 2009
March 13, 2012
April 2009
Not Provided
Efficacy and Safety of Kogenate FS [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00932555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.

Hemophilia A
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients under daily life treatment receiving Kogenate according to local drug information.
Group 1
Intervention: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
December 2011
Not Provided

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.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00932555
14344, KG0803
No
Medical Director, Bayer Taiwan LTD
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP