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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017301-11 | EudraCT Number | ||
| 1498 | Other Identifier | CSL Behring |
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The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biostate | Biological | Single bolus doses, administered intravenously. Frequency and dose will be determined by the Investigator based on the subjects clinical condition, previous VWF concentrate requirements, response to therapy, weight and reason for usage. |
| Measure | Description | Time Frame |
|---|---|---|
| Haemostatic efficacy | Up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Development of FVIII inhibitors | Up to 32 months | |
| Development of VWF inhibitors | Up to 32 months | |
| Frequency of Adverse events (AEs) per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director, Clinical R&D | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Sofia | Bulgaria | ||||
| Study Site |
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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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| 32 months |
| Severity of AEs per subject | 32 months |
| Severity of AEs per infusion | 32 months |
| Causality of AEs per subject | 32 months |
| Causality of AEs per infusion | 32 months |
| Frequency of Adverse events (AEs) per infusion | 32 months |
| Bremen |
| Germany |
| Study Site | Warsaw | Poland |
| Study Site | Wroclaw | Poland |
| Study Site | Barnaul | Russia |
| Study Site | Lviv | Ukraine |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |