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

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

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Haemophilia A patients

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Haemophilia A patients

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Bahrain

Site Status

Many Locations, , Bosnia and Herzegovina

Site Status

Many Locations, , Croatia

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Israel

Site Status

Many Locations, , Kazakhstan

Site Status

Many Locations, , Kuwait

Site Status

Many Locations, , Libya

Site Status

Many Locations, , Morocco

Site Status

Many Locations, , Oman

Site Status

Many Locations, , Qatar

Site Status

Many Locations, , Romania

Site Status

Many Locations, , Russia

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , Slovenia

Site Status

Many Locations, , Tunisia

Site Status

Many Locations, , United Arab Emirates

Site Status

Countries

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Bahrain Bosnia and Herzegovina Croatia Germany Israel Kazakhstan Kuwait Libya Morocco Oman Qatar Romania Russia Saudi Arabia Slovenia Tunisia United Arab Emirates