To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

Study Overview
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Brief Summary
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This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.

Official Title
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A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan

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: Informed 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 the diagnosis of haemophilia A Age range is 0 year and above A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician Exclusion Criteria: Known or suspected allergy to study product(s) or related products Previous participation in this study. Participation is defined as informed consent obtained 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 |
| --- | --- |
| NovoEight®<br> | Drug: turoctocog alfa<br>* No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction 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 Events (AEs) |  | Week 0- 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Reactions (ARs) |  | Week 0- 104 | 
| Frequency of Serious Adverse Events (SAEs) |  | Week 0- 104 | 
| Frequency of Serious Adverse Reactions (SARs) |  | Week 0- 104 | 
| Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively |  | Week 0- 104 | 
| Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None |  | Week 0- 104 | 
| Annualised bleeding rate for patients using NovoEight® for preventive regimen |  | Week 0- 104 | 
| Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient) |  | Week 0- 104 | 
| Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) |  | Week 0- 104 | 
| Consumption of NovoEight® per month (IU/kg BW/month) for prevention |  | Week 0- 104 | 
| Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen |  | Week 0- 104 |