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International PMS Study - KOGENATE Bayer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864552
First Posted: March 18, 2009
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864552


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

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov 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
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by Bayer:
Hemophilia A
Recombinant Factor VIII

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants