Trial Condition(s):

Hemophilia A

Kogenate FS regulatory Post-Marketing Surveillance (KG0910KR)

Bayer Identifier:

14927

ClinicalTrials.gov Identifier:

NCT01386268

EudraCT 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
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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
Status
LocationsStatus
Locations

Investigative Site

Many locations, South Korea

Status
Completed
 

Trial Design