International PMS Study - KOGENATE Bayer

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00864552
First received: March 17, 2009
Last updated: June 29, 2009
Last verified: June 2009

March 17, 2009
June 29, 2009
December 2002
Not Provided
Not Provided
Long-term safety (number and kind of adverse events)
Complete list of historical versions of study NCT00864552 on ClinicalTrials.gov Archive Site
Not Provided
  • Long-term efficacy (consumption)
  • Patient acceptance
  • To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix tween
Not Provided
Not Provided
 
International PMS Study - KOGENATE Bayer
International PMS Study - KOGENATE Bayer

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.

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

Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

Hemophilia A
Drug: Kogenate (BAY14-2222)
Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
Group 1
Intervention: Drug: Kogenate (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
200
December 2005
Not Provided

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)
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Greece,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland
 
NCT00864552
11145, 12252 - KG0201CH,, 12253 - KG0201BE,, 12256 - KG0201AT,, 12258 - KG0201IT,, 12259 - KG0201GR,, 12260 - KG0201ES,, 12261 - KG0201FR,, 12264 - KG0201SE,, 12266 - KG0201NL
No
Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2009

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