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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
History of Changes
  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:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

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
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, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013