Kogenate FS Regulatory Post-Marketing Surveillance (KG0910KR)

Bayer

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type: Observational

Funder types: Industry

Identifiers

NCT01386268

14927

KG0910KR (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

64 participants in 1 patient group

Group 1

Treatment:

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)