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The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.
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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 |
|---|---|---|
| Assessment of control of prevention of bleeding | Investigator's assessment as excellent, good, moderate or none. | End of study (Day 5 to Day 10) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road | Basingstoke | RG24 9NA | United Kingdom | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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| Haemophilia Centre, The Royal London Hospital, White Chapel |
| London |
| E1 1BB |
| United Kingdom |
| Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street | London | NW3 2QG | United Kingdom |
| Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road | Manchester | M13 9WL | United Kingdom |
| Haemophilia Centre, Southampton General Hospital, Tremona Road | Southampton | SO16 6YD | 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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