Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.

Official Title
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Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan

Conditions
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Haemophilia A

Intervention / Treatment
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* Drug: Turoctocog alfa pegol


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). The decision to initiate treatment with commercially available Esperoct® 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. Diagnosis of haemophilia A in males or females, no age limitation. New patients who have not previously been exposed to Esperoct®. Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study. Known or suspected hypersensitivity to study product or related products. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia A<br>New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study. | Drug: Turoctocog alfa pegol<br>* Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse reactions (ARs) reported during the observation period | Count | From baseline (week 0) to end of study (week 104) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events (SAEs) reported during the observation period | Count | From baseline (week 0) to end of study (week 104) | 
| Number of serious adverse reactions (SARs) reported during the observation period | Count | From baseline (week 0) to end of study (week 104) | 
| Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period | Count | From baseline (week 0) to end of study (week 104) | 
| Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR) | Count | From baseline (week 0) to end of study (week 104) | 
| Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds | Count, assessed based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure | From baseline (week 0) to end of study (week 104) | 
| Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures | Count, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure | From baseline (week 0) to end of study (week 104) |