Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.

Official Title
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24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: efmoroctocog alfa
* Drug: Factor VIII


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients with a diagnosis of haemophilia A Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit Signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations Exclusion Criteria: Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment Previously treated with commercially available extended half-life products other than Elocta Presence of factor VIII inhibitors (≥0.60 Bethesda Unit [BU]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay
Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Elocta<br>Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice | Drug: efmoroctocog alfa<br>* extended half-life factor VIII product<br>* Other names: Elocta;|
| Conventional factor VIII product<br>Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice | Drug: Factor VIII<br>* conventional factor VIII product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualised bleeding rate (ABR) |  | 24 months | 
| Annualised injection frequency |  | 24 months | 
| Annualised factor consumption (International Unit [IU]) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Coagulation Disorders, Hematologic Diseases, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn