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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elocta | Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice |
| |
| Conventional factor VIII product | Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efmoroctocog alfa | Drug | extended half-life factor VIII product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualised bleeding rate (ABR) | 24 months | |
| Annualised injection frequency | 24 months | |
| Annualised factor consumption (International Unit [IU]) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients with a diagnosis of haemophilia A prescribed prophylactic treatment with Elocta or conventional factor product
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| Name | Affiliation | Role |
|---|---|---|
| Study Physician, MD | Sweden Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum Research site | Innsbruck | Austria | ||||
| Swedish Orphan Biovitrum Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616274 | Derived | Oldenburg J, Hay C, Peyvandi F, Lehtinen AE, Pabinger I, Nuesch E, Malmstrom H, Bednar E, Lethagen S. A-SURE: intra-patient comparison of prophylactic effectiveness of a recombinant factor VIII Fc fusion protein versus standard half-life factor VIII in hemophilia A. Hematology. 2025 Dec;30(1):2513186. doi: 10.1080/16078454.2025.2513186. Epub 2025 Jul 4. | |
| 31152037 |
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| Factor VIII | Drug | conventional factor VIII product |
|
| Linz |
| Austria |
| Swedish Orphan Biovitrum Research Site | Sankt Pölten | Austria |
| Swedish Orphan Biovitrum Research site | Vienna | Austria |
| Swedish Orphan Biovitrum Research site | Brussels | Belgium |
| Swedish Orphan Biovitrum Research site | Helsinki | Finland |
| Swedish Orphan Biovitrum Research site | Caen | France |
| Swedish Orphan Biovitrum Research site | Montpellier | France |
| Swedish Orphan Biovitrum Research site | Nancy | France |
| Swedish Orphan Biovitrum Research site | Rennes | France |
| Swedish Orphan Biovitrum Reserach site | Catanzaro | Italy |
| Swedish Orphan Biovitrum Reserach site | Florence | Italy |
| Swedish Orphan Biovitrum Research site | Milan | Italy |
| Swedish Orphan Biovitrum Reserach site | Naples | Italy |
| Swedish Orphan Biovitrum Research Site | Padova | Italy |
| Swedish Orphan Biovitrum Reserach site | Palermo | Italy |
| Swedish Orphan Biovitrum Reserach site | Parma | Italy |
| Swedish Orphan Biovitrum Reserach site | Rome | Italy |
| Swedish Orphan Biovitrum Research site | Turin | Italy |
| Swedish Orphan Biovitrum Research site | Oslo | Norway |
| Swedish Orphan Biovitrum research site | Alicante | Spain |
| Swedish Orphan Biovitrum Reserach site | Barcelona | Spain |
| Swedish Orphan Biovitrum Reserach site | Madrid | Spain |
| Swedish Orphan Biovitrum Research site | Málaga | Spain |
| Swedish Orphan Biovitrum Reserach site | Seville | Spain |
| Swedish Orphan Biovitrum Research site | Valencia | Spain |
| Swedish Orphan Biovitrum Research site | Gothenburg | Sweden |
| Swedish Orphan Biovitrum Research site | Malmö | Sweden |
| Swedish Orphan Biovitrum Research site | Stockholm | Sweden |
| Swedish Orphan Biovitrum Research site | Birmingham | United Kingdom |
| Swedish Orphan Biovitrum Research site | Canterbury | United Kingdom |
| Swedish Orphan Biovitrum Research site | Liverpool | United Kingdom |
| Swedish Orphan Biovitrum Reserach site | London | United Kingdom |
| Swedish Orphan Biovitrum Research site | Manchester | United Kingdom |
| Swedish Orphan Biovitrum Research site | Sheffield | United Kingdom |
| Swedish Orphan Biovitrum Research site | Southampton | United Kingdom |
| Oldenburg J, Hay CRM, Jimenez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012. |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C587014 | factor VIII-Fc fusion protein |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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