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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Many Locations, Austria

2

Many Locations, Belgium

3

Many Locations, Denmark

4

Many Locations, France