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As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented.
It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with von Willebrand disease treated with Humate P® ivr in Canada |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of Humate-P® (reported adverse events) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with von Willebrand disease treated with Humate P® ivr in Canada
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| Name | Affiliation | Role |
|---|---|---|
| David G. Barnes, Dr. | CSL Behring Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Canada |
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| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |