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Kogenate FS Regulatory Post-Marketing Surveillance (KG0910KR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386268
First Posted: July 1, 2011
Last Update Posted: August 21, 2014
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 (Responsible Party):
Bayer
  Purpose

To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: KOGENATE® FS , Local Post Authorization Safety Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Up to 6 months ]

Secondary Outcome Measures:
  • Type of the treatment (prophylaxis, on demand, surgery) [ Time Frame: Initial visit and 6 month f/u or at the end of the observation visit ]
  • Total consumption of FVIII [ Time Frame: Initial visit and 6 month f/u or at the end of the observation visit ]
  • Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively) [ Time Frame: Initial visit, 6 month follow-up visit and 12 month follow-up visit ]
  • General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient [ Time Frame: 6 month f/u or at the end of observation visit ]

Enrollment: 64
Study Start Date: June 2011
Study Completion Date: August 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia A in Korea
Criteria

Inclusion Criteria:

  • Patients with diagnosis of hemophilia A
  • Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
  • Signed the informed consent form to participate in this study.
  • 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
  • For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
  • Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

  • Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
  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): NCT01386268


Locations
Korea, Republic of
Many locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01386268     History of Changes
Other Study ID Numbers: 14927
KG0910KR ( Other Identifier: Company Internal )
First Submitted: June 14, 2011
First Posted: July 1, 2011
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Bayer:
Kogenate FS
Hemophilia 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