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EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

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ClinicalTrials.gov Identifier: NCT00874926
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

Condition or disease Intervention/treatment
Hemophilia A Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Design
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Study Type : Observational
Actual Enrollment : 405 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Study Start Date : June 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haemophilia A patients, no specific study population
Criteria

Inclusion Criteria:

  • Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
Contacts and Locations
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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): NCT00874926


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00874926     History of Changes
Other Study ID Numbers: 13405
KG0702 ( Other Identifier: company internal )
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Bayer:
Octocog alfa
Haemophilia A
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants