EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00874926
First received: April 2, 2009
Last updated: January 28, 2014
Last verified: January 2014

April 2, 2009
January 28, 2014
June 2008
November 2012   (final data collection date for primary outcome measure)
Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ] [ Designated as safety issue: Yes ]
Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00874926 on ClinicalTrials.gov Archive Site
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EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

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

Haemophilia A patients, no specific study population

Hemophilia A
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients
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
405
April 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/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 Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Morocco,   Bosnia and Herzegovina,   Croatia,   Germany,   Israel,   Kazakhstan,   Kuwait,   Libyan Arab Jamahiriya,   United Arab Emirates,   Oman,   Qatar,   Romania,   Russian Federation,   Saudi Arabia,   Slovenia,   Tunisia,   Bahrain
 
NCT00874926
13405, KG0702
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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