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Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haemophilia A patients | Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment |
| |
| Haemophilia B patients | Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELOCTA | Drug | Extended half-life factor VIII product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualised bleeding rate (ABR) | Based on bleeding episodes assessed by local practice | 24 months |
| Annualised injection frequency | Assessed by prescription | 24 months |
| Annualised factor consumption (IU) | Assessed by dispensed factor product | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible Elocta and Alprolix 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 Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Study Physician, MD | Swedish Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum Reserach site | Berlin | Germany | ||||
| Swedish Orphan Biovitrum Reserach Site |
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| ALPROLIX | Drug | Extended half-life factor IX product |
|
|
| Blaubeuren Abbey |
| Germany |
| Swedish Orphan Biovitrum Research Site | Bonn | Germany |
| Swedish Orphan Biovitrum Research Site | Delmenhorst | Germany |
| Swedish Orphan Biovitrum Research Site | Duisburg | Germany |
| Swedish Orphan Biovitrum Reserach site | Erlangen | Germany |
| Swedish Orphan Biovitrum Research Site | Frankfurt | Germany |
| Swedish Orphan Biovitrum Reserach site | Frankfurt | Germany |
| Swedish Orphan Biovitrum Research Site | Fürth | Germany |
| Swedish Orphan Biovitrum Research Site | Hamburg | Germany |
| Swedish Orphan Biovitrum Research Site | Hanover | Germany |
| Swedish Orphan Biovitrum Reserach site | Hanover | Germany |
| Swedish Orphan Biovitrum Reserach site | Heidelberg | Germany |
| Swedish Orphan Biovitrum Reserach site | Homburg | Germany |
| Swedish Orphan Biovitrum Research Site | Jena | Germany |
| Swedish Orphan Biovitrum Reserach Site | Jena | Germany |
| Swedish Orphan Biovitrum Reserach site | Leipzig | Germany |
| Swedish Orphan Biovitrum Reserach Site | Mörfelden-Walldorf | Germany |
| Swedish Orphan Biovitrum Research Site | München | Germany |
| Swedish Orphan Biovitrum Reserach site | München | Germany |
| Swedish Orphan Biovitrum Reserach site | Münster | Germany |
| Swedish Orphan Biovitrum Research Site | Würzburg | Germany |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
|---|---|
| C587014 | factor VIII-Fc fusion protein |
| C000599709 | factor IX Fc fusion protein |
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