Trial Condition(s):
Hemophilia A
Kogenate FS regulatory Post-Marketing Surveillance (KG0910KR)
Bayer Identifier:
14927
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial 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.
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.
Trial Summary
Enrollment Goal
64
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
KOGENATE® FS , Local Post Authorization Safety Study
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: Up to 6 months
Secondary Outcome
- Type of the treatment (prophylaxis, on demand, surgery)Timeframe: Initial visit and 6 month f/u or at the end of the observation visit
- Total consumption of FVIIITimeframe: 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)Timeframe: 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) insufficientTimeframe: 6 month f/u or at the end of observation visit
Additional Information
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