Brief Title
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Official Title
Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Brief Summary
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.
Study Type
Observational
Primary Outcome
Efficacy and Safety of Kogenate Bayer/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
405
Start Date
June 2008
Completion Date
April 2013
Primary Completion Date
November 2012
Eligibility Criteria
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.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Bahrain
Location Countries
Bahrain
Administrative Informations
NCT ID
NCT00874926
Organization ID
13405
Secondary IDs
KG0702
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
January 2014