Status:
COMPLETED
International PMS Study - KOGENATE Bayer
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
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 e...
Eligibility Criteria
Inclusion
- Patients with severe haemophilia A (\<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
Exclusion
- Exclusion criteria must be read in conjunction with the product information (SmPC)
Key Trial Info
Start Date :
December 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00864552
Start Date
December 1 2002
End Date
December 1 2005
Last Update
June 30 2009
Active Locations (10)
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1
Many Locations, Austria
2
Many Locations, Belgium
3
Many Locations, Denmark
4
Many Locations, France