Brief Title
Kogenate FS Regulatory Post-Marketing Surveillance
Official Title
KOGENATE® FS , Local Post Authorization Safety Study
Brief Summary
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.
Study Type
Observational
Primary Outcome
Safety variables will be summarized using descriptive statistics based on adverse events collection
Secondary Outcome
Type of the treatment (prophylaxis, on demand, surgery)
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
64
Start Date
June 2011
Completion Date
August 2013
Primary Completion Date
January 2013
Eligibility 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01386268
Organization ID
14927
Secondary IDs
KG0910KR
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
August 2014