Hemophilia A Clinical Trial
— KG0910KROfficial title:
KOGENATE® FS , Local Post Authorization Safety Study
Verified date | August 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
Study type | Observational |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | August 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety variables will be summarized using descriptive statistics based on adverse events collection | Up to 6 months | Yes | |
Secondary | Type of the treatment (prophylaxis, on demand, surgery) | Initial visit and 6 month f/u or at the end of the observation visit | No | |
Secondary | Total consumption of FVIII | Initial visit and 6 month f/u or at the end of the observation visit | No | |
Secondary | Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively) | Initial visit, 6 month follow-up visit and 12 month follow-up visit | No | |
Secondary | General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient | 6 month f/u or at the end of observation visit | No |
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