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To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.
For the treatment of surgical procedures the intended dose of Alphanate® will be given as a single dose or as multiple doses over several days, depending on the clinical situation, and according to the Full Prescribing Information guideline and the investigator's judgment. For each treated event, the subject's treatment period will be finished when, in the opinion of the local Investigator, the participating subject would not benefit from further infusions of the study concentrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coagulation FVIII/VWF | Experimental | Anti-Hemophilic/von Willebrand Factor VIII (Human) Alphanate SD/HT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alphanate SD/HT | Biological | A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures (mostly major surgeries). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the Day 0 (surgery day) and Day 1 (post-surgery day) treatment outcomes of each surgical procedure, rated by the investigator using a 2-point verbal rating scale. | 1 Day | |
| Assessment of Safety and Tolerability | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Pinciaro, PhD | Grifols Biologicals, LLC | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 5, 2025 | |
| Reset | Aug 19, 2025 | |
| Release | May 20, 2026 | |
| Reset | Jun 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 5, 2025 | Aug 19, 2025 | |||
| May 20, 2026 |
| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| D006467 | Hemophilia A |
| D020141 | Hemostatic Disorders |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
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|
|
| Jun 16, 2026 |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |