International PMS Study - KOGENATE Bayer

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-12-31

Brief Summary

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To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.

To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Detailed Description

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Conditions

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Hemophilia A

Keywords

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Hemophilia A Recombinant Factor VIII

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Kogenate (BAY14-2222)

Intervention Type DRUG

Patients with severe haemophilia A (\<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

Interventions

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Kogenate (BAY14-2222)

Patients with severe haemophilia A (\<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with severe haemophilia A (\<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Austria

Site Status

Many Locations, , Belgium

Site Status

Many Locations, , Denmark

Site Status

Many Locations, , France

Site Status

Many Locations, , Greece

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Netherlands

Site Status

Many Locations, , Spain

Site Status

Many Locations, , Sweden

Site Status

Many Locations, , Switzerland

Site Status

Countries

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Austria Belgium Denmark France Greece Italy Netherlands Spain Sweden Switzerland