International PMS Study - KOGENATE Bayer

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

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.

Condition Intervention
Hemophilia A
Drug: Kogenate (BAY14-2222)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International PMS Study - KOGENATE Bayer

Resource links provided by NLM:

Further study details as provided by Bayer:

Enrollment: 200
Study Start Date: December 2002
Study Completion Date: December 2005
Groups/Cohorts Assigned Interventions
Group 1 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


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00864552

Many Locations, Austria
Many Locations, Belgium
Many Locations, Denmark
Many Locations, France
Many Locations, Greece
Many Locations, Italy
Many Locations, Netherlands
Many Locations, Spain
Many Locations, Sweden
Many Locations, Switzerland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00864552     History of Changes
Other Study ID Numbers: 11145, 12252 - KG0201CH,, 12253 - KG0201BE,, 12256 - KG0201AT,, 12258 - KG0201IT,, 12259 - KG0201GR,, 12260 - KG0201ES,, 12261 - KG0201FR,, 12264 - KG0201SE,, 12266 - KG0201NL
Study First Received: March 17, 2009
Last Updated: June 29, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Bayer:
Hemophilia A
Recombinant Factor VIII

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2015