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

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

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Coagulation Disorders Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type BIOLOGICAL

Patients under daily life treatment receiving Kogenate according to local drug information.

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Patients under daily life treatment receiving Kogenate according to local drug information.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No