Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

• turoctocog alfa (Drug): 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.

Primary outcomes

• 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 [Within approximately 7 years]

Secondary outcomes

• Number of adverse reactions reported [During approximately 7 years]
• Number of serious adverse reactions reported [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 [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 [Within approximately 7 years]
• Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [Within approximately 7 years]
• Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [Within approximately 7 years]

Sex: Male

Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
* Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
* The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
* A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

Exclusion Criteria:

* Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Previous participation in any clinical trial with turoctocog alfa
* Treatment with other FVIII products after initiation of treatment with turoctocog alfa

• Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S