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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00874926
First received: April 2, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Hemophilia A
 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 405
Study Start Date: June 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874926

  Show 17 Study Locations
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: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00874926     History of Changes
Other Study ID Numbers: 13405, KG0702
Study First Received: April 2, 2009
Last Updated: February 6, 2013
Health Authority: Bosnia: Federal Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Kazakhstan: Ethical Commission
Morocco: Ministry of Public Health
Croatia: Ethics Committee
Israel: Ethics Commission
Russia: Ethics Committee
Slovenia: Ethics Committee
Romania: Ethics Committee
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Tunisia: Office of Pharmacies and Medicines
Lybia: Ethics Committee

Keywords provided by Bayer:
Octocog alfa
Haemophilia A

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 18, 2013