Kogenate FS Regulatory Post-Marketing Surveillance

Completed

• Conditions: Hemophilia A
• Interventions: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

• Registration Number: NCT01386268
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Primary Completion: 2013-01
• Study Completion: 2013-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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Exclusion Criteria

• Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Recombinant Factor VIII (Kogenate FS, BAY14-2222)	-

Primary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse events collection	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)	Initial visit, 6 month follow-up visit and 12 month follow-up visit
Type of the treatment (prophylaxis, on demand, surgery)	Initial visit and 6 month f/u or at the end of the observation visit
Total consumption of FVIII	Initial visit and 6 month f/u or at the end of the observation visit
General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient	6 month f/u or at the end of observation visit