Kogenate FS Regulatory Post-Marketing Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type BIOLOGICAL

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

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.