Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Completed

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

• Registration Number: NCT00969319
• Lead Sponsor: Bayer

Brief Summary

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS 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 First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study Start: 2009-09
• Study First Posted: 2009-09-01
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

• Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® 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

Not provided

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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
Kind of bleedings	After 12 months and after 24 months
Continuation of therapy	After 12 months and after 24 months
Overall assessment by the physician	After 12 months and after 24 months
Total consumption of FVIII	After 12 months and after 24 months
Number of bleedings	After 12 months and after 24 months

Secondary Outcome Measures

Name	Time	Method
Adverse event collection	After 12 months and after 24 months