check_circleStudy Completed

Hemophilia A

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