check_circleStudy Completed

Hemophilia A

Bayer Identifier:

14927

ClinicalTrials.gov Identifier:

NCT01386268

EudraCT Number:

Not Available

EU CT Number:

Not Available
Kogenate FS regulatory Post-Marketing Surveillance

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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.

  • - 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
June 2011 - August 2013
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Korea, Republic Of

Primary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Type of the treatment (prophylaxis, on demand, surgery)
    date_rangeTime Frame:
    Initial visit and 6 month f/u or at the end of the observation visit
    enhanced_encryption
    Safety Issue:
    No
  • Total consumption of FVIII
    date_rangeTime Frame:
    Initial visit and 6 month f/u or at the end of the observation visit
    enhanced_encryption
    Safety Issue:
    No
  • Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)
    date_rangeTime Frame:
    Initial visit, 6 month follow-up visit and 12 month follow-up visit
    enhanced_encryption
    Safety Issue:
    No
  • General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient
    date_rangeTime Frame:
    6 month f/u or at the end of observation visit
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results