Kogenate FS Regulatory Post-Marketing Surveillance

Brief Title

Kogenate FS Regulatory Post-Marketing Surveillance

Official Title

KOGENATE® FS , Local Post Authorization Safety Study

Brief Summary

      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.

Study Type

Observational

Primary Outcome

Safety variables will be summarized using descriptive statistics based on adverse events collection

Secondary Outcome

 Type of the treatment (prophylaxis, on demand, surgery)

Condition

Hemophilia A

Intervention

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Arms / Comparison Groups

 Group 1

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

June 2011

Completion Date

August 2013

Primary Completion Date

January 2013

Eligibility Criteria

        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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, ,

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT01386268

Organization ID

Secondary IDs

KG0910KR

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

August 2014