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Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic patients | Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment |
| |
| On demand patients | Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprolix | Drug | Extended half-life factor IX product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualised bleeding rate (ABR) (prophylactic treatment) | Assessed by diary | 24 months |
| Annualised injection frequency (prophylactic treatment) | Assessed by diary | 24 months |
| Annualised factor consumption (International Unit [IU]) (prophylactic treatment) | Assessed by diary | 24 months |
| Amount of factor Product used to treat a bleed (on-demand treatment) | Assessed by diary | 24 months |
| Number of injections to treat a bleed (on-demand treatment) | Assessed by diary | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres in France.
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| Name | Affiliation | Role |
|---|---|---|
| Elena Santagostino, MD | Swedish Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum Research Site (CHU de Bordeaux) | Bordeaux | France | ||||
| Swedish Orphan Biovitrum Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39872008 | Derived | Chambost H, Repesse Y, Genre-Volot F, Desprez D, Castet SM, Vanderbecken S, Zidi M, Gandossi C, Nuesch E, Palmborg H, Santagostino E; B-SURE Study Group. Real-world usage and effectiveness of recombinant factor IX Fc in haemophilia B from the B-SURE study in France. Ther Adv Hematol. 2025 Jan 26;16:20406207241311535. doi: 10.1177/20406207241311535. eCollection 2025. |
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| Brest |
| France |
| Swedish Orphan Biovitrum Research Site | Caen | France |
| Swedish Orphan Biovitrum Research Site | Chambéry | France |
| Swedish Orphan Biovitrum Research Site | Clermont-Ferrand | France |
| Swedish Orphan Biovitrum Research Site | Dijon | France |
| Swedish Orphan Biovitrum Research Site | La Réunion | France |
| Swedish Orphan Biovitrum Research Site | Lille | France |
| Swedish Orphan Biovitrum Research Site | Marseille | France |
| Swedish Orphan Biovitrum Research Site | Montpellier | France |
| Swedish Orphan Biovitrum Research Site | Nantes | France |
| Swedish Orphan Biovitrum Research Site | Nîmes | France |
| Swedish Orphan Biovitrum research site | Paris | France |
| Swedish Orphan Biovitrum research site | Poitiers | France |
| Swedish Orphan Biovitrum research site | Rennes | France |
| Swedish Orphan Biovitrum Research Site | Rouen | France |
| Swedish Orphan Biovitrum research site | Strasbourg | France |
| Swedish Orphan Biovitrum Research Site | Toulouse | France |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| 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 |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| C000599709 | factor IX Fc fusion protein |
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