EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Completed

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

• Registration Number: NCT00874926
• Lead Sponsor: Bayer

Brief Summary

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2012-11
• Study Completion: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 405

Inclusion Criteria

• Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. 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.

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information.

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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
Efficacy and Safety of Kogenate Bayer/FS	After 12 months, after 24 months