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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932555
First Posted: July 3, 2009
Last Update Posted: March 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
July 2, 2009
July 3, 2009
March 14, 2012
April 2009
Not Provided
Efficacy and Safety of Kogenate FS [ Time Frame: After 12 months and after 24 months ]
Same as current
Complete list of historical versions of study NCT00932555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00932555
14344
KG0803 ( Other Identifier: company internal )
No
Not Provided
Not Provided
Medical Director, Bayer Taiwan LTD
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2012