This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
Study Type
OBSERVATIONAL
Enrollment
69
Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
Time frame: Within approximately 7 years
Number of adverse reactions reported
Time frame: During approximately 7 years
Number of serious adverse reactions reported
Time frame: During approximately 7 years
Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None
Time frame: Within approximately 7 years
Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
Time frame: Within approximately 7 years
Annualised bleeding rate for patients using turoctocog alfa for preventive treatment
Time frame: Within approximately 7 years
Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment
Time frame: Within approximately 7 years
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Novo Nordisk Investigational Site
Mobile, Alabama, United States
Novo Nordisk Investigational Site
Torrance, California, United States
Novo Nordisk Investigational Site
Peoria, Illinois, United States
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States
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Charlotte, North Carolina, United States
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Salt Lake City, Utah, United States
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Graz, Austria
Novo Nordisk Investigational Site
Linz, Austria
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Brno, Czechia
Novo Nordisk Investigational Site
Bordeaux, France
...and 31 more locations