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To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.
To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Replenine®-VF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Replenine®-VF (High Purity Factor IX) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later. | Safety assessments included:
| Baseline and 3 months post-baseline. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Hematologii Instytutu Medycyny Wewnetrznej | Lodz | Poland | ||||
| Klinika Hematologii AM Lublin, ul.Jaczewskiego 8 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Lublin |
| Poland |
| Addenbrooke's Hospital, Hills Road | Cambridge | United Kingdom |
| University Hospital of Wales, Heath Park | Cardiff | United Kingdom |
| The Royal London Hospital | London | United Kingdom |
| Manchester Royal Infirmary, Oxford Road | Manchester | United Kingdom |
| Norwich and Norfolk Hospital | Norwich | United Kingdom |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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