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Kogenate FS Regulatory Post-Marketing Surveillance (KG0910KR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01386268
First received: June 14, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Total consumption of FVIII [ Time Frame: Initial visit and 6 month f/u or at the end of the observation visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: July 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01386268     History of Changes
Other Study ID Numbers: 14927, KG0910KR
Study First Received: June 14, 2011
Last Updated: May 17, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013