Brief Title
International PMS Study - KOGENATE Bayer
Official Title
International PMS Study - KOGENATE Bayer
Brief Summary
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
Study Type
Observational
Condition
Hemophilia A
Intervention
Kogenate (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
Drug
Estimated Enrollment
200
Start Date
December 2002
Completion Date
December 2005
Eligibility Criteria
Inclusion Criteria: - Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII Exclusion Criteria: - Exclusion criteria must be read in conjunction with the product information (SmPC)
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00864552
Organization ID
11145
Secondary IDs
12252 - KG0201CH,
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
June 2009