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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) | Bleeding episodes assessed according to local practice | 24 months |
| Annualised injection frequency | Assessed by prescription | 24 months |
| Annualised factor consumption | Assessed by dispensed factor product | 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.
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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 | Brno | Czechia | ||||
| Swedish Orphan Biovitrum Research Site |
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| Prague |
| Czechia |
| Swedish Orphan Biovitrum Research Site (Haemophilia Center Aghia Sophia Children's Hospital) | Athens | Greece |
| Swedish Orphan Biovitrum Research Site (Laikο General Hospital of Athens) | Athens | Greece |
| Swedish Orphan Biovitrum Research Site | Dublin | Ireland |
| Swedish Orphan Biovitrum Research Site | Bari | Italy |
| Swedish Orphan Biovitrum Research Site | Florence | Italy |
| Swedish Orphan Biovitrum Research Site | Genova | Italy |
| Swedish Orphan Biovitrum Research Site | Milan | Italy |
| Swedish Orphan Biovitrum Research Site | Roma | Italy |
| Swedish Orphan Biovitrum Research Site | Turin | Italy |
| Swedish Orphan Biovitrum Research Site | Oslo | Norway |
| Swedish Orphan Biovitrum Research Site (King Faisal Hospital adult) | Riyadh | Saudi Arabia |
| Swedish Orphan Biovitrum Research Site (King Faisal Hospital pediatric) | Riyadh | Saudi Arabia |
| Swedish Orphan Biovitrum Research Site (Hospital de Vall d'Hebrón) | Barcelona | Spain |
| Swedish Orphan Biovitrum Research Site (Hospital Sant Joan de Deu) | Barcelona | Spain |
| Swedish Orphan Biovitrum Research Site | Murcia | Spain |
| Swedish Orphan Biovitrum Research Site | Vigo | Spain |
| Swedish Orphan Biovitrum Research Site | Gothenburg | Sweden |
| Swedish Orphan Biovitrum Research Site | Malmö | Sweden |
| Swedish Orphan Biovitrum Research Site (Karolinska University Hospital adult) | Stockholm | Sweden |
| Swedish Orphan Biovitrum Research Site (Karolinska University Hospital pediatric) | Stockholm | Sweden |
| Swedish Orphan Biovitrum Research Site | Hull | United Kingdom |
| Swedish Orphan Biovitrum Research Site | London | NW3 2QG | United Kingdom |
| Swedish Orphan Biovitrum Research Site | London | SE1 7EH | United Kingdom |
| Swedish Orphan Biovitrum Research Site | London | W12 0HS | United Kingdom |
| Swedish Orphan Biovitrum Research Site | London | WC1N 3JH | United Kingdom |
| Swedish Orphan Biovitrum Research Site | Manchester | United Kingdom |
| Swedish Orphan Biovitrum Research Site | Oxford | United Kingdom |
| 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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