International PMS Study - KOGENATE Bayer

Bayer200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Hemophilia A

Interventions

Kogenate (BAY14-2222)DRUG

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with severe haemophilia A (\<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII Exclusion Criteria: * Exclusion criteria must be read in conjunction with the product information (SmPC)

Locations (10)

Unnamed facility

Many Locations, Austria

Unnamed facility

Many Locations, Belgium

Unnamed facility

Many Locations, Denmark

Unnamed facility

Many Locations, France

Data from ClinicalTrials.gov

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