Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Study Overview
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Brief Summary
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The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico

Official Title
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Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Conditions
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Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
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* Drug: turoctocog alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) Male and female patients with haemophilia A Age range is 0 years and above The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study Known or suspected allergy to turoctocog alfa or related products Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| turoctocog alfa<br>Patients with haemophilia A | Drug: turoctocog alfa<br>* Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse reactions | Count and % of events | 3-36 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events | Count and % of events | 3-36 months after enrollment | 
| Efficacy in treatment of bleeds | Rated: Excellent, Good, Moderate or none | 3-36 months after enrollment | 
| Consumption of turoctocog alfa for prophylaxis | Measured in IU/kg/dose | 3-36 months after enrollment | 
| Consumption of turoctocog alfa for treatment of bleeds | Measured in IU/kg/bleeding episode | 3-36 months after enrollment | 
| Consumption of turoctocog alfa for surgery and post-surgical period | Measured in IU/kg | 3-36 months after enrollment | 
| Number of patients with confirmed inhibitors | Count of presence of inhibitors | 3-36 months after enrollment | 
| Number of patients with allergic/hypersensitivity reactions to turoctocog alfa | Count of episodes | 3-36 months after enrollment | 
| Number of bleeding episodes | Count of episodes | 3-36 months after enrollment |