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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003305-25 | EudraCT Number |
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This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD) in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose prescribed by the Investigator in accordance with the Voncento Summary of Product Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a frequency of 1-3 times per week). Voncento will also be given to prevent and treat any surgical bleeding events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voncento | Experimental | The frequency and dose of Voncento administration will be determined by the investigator using the information included in the Voncento Summary of product characteristics (SmPC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voncento | Biological | Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemostatic efficacy - NSB event | Subject's and investigator's assessment of haemostatic efficacy of Voncento in its usage for a non-surgical bleeding (NSB) event. Assessments of haemostatic efficacy will be based on a 4-point ordinal scale of Excellent, Good, Moderate or None. | Assessed daily by the subject until the bleed stops, for the duration of the subject's participation in the study (approximately 12 months). Each bleeding event is also to be assessed retrospectively by the Investigator. |
| Number of infusions - NSB event | Number of infusions of Voncento required to treat an NSB event. | For the duration of the subject's participation in the study (approximately 12 months). |
| Total dose of Voncento - NSB event | Total dose of Voncento (in international units of Von Willebrand Factor: Ristocetin Cofactor) required to treat an NSB event. | For the duration of the subject's participation in the study (approximately 12 months). |
| Number of NSB events per month | From Day 1 until final study visit, approximately 12 months. | |
| Annual bleeding rate | The number of bleeding events per year | For the duration of the subject's participation in the study (approximately 12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of blood loss during a surgical procedure | During surgery, for any surgical procedure during the subject's participation in the study (approximately 12 months). | |
| Haemostatic efficacy - surgical event | Investigator's or surgeon's assessment of haemostatic efficacy of Voncento in its usage for a surgical bleeding event. Assessments of haemostatic efficacy will be based on a 4-point ordinal scale of Excellent, Good, Moderate or None. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Vienna | Austria | ||||
| Study Site |
| 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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| Assessed during and after surgery until the bleeding stops, for any surgical procedure during the subject's participation in the study (approximately 12 months). |
| Number of infusions - surgical bleeding event | Number of infusions of Voncento required to treat a surgical bleeding event. | For the duration of the subject's participation in the study (approximately 12 months). |
| Total dose of Voncento - surgical bleeding event | Total dose of Voncento (in international units of Von Willebrand Factor: Ristocetin Cofactor) required to treat a surgical bleeding event. | For the duration of the subject's participation in the study (approximately 12 months). |
| Overall adverse events | Overall number of subjects with: adverse events (AEs), serious AEs, AEs related to Voncento administration, and adverse events of special interest. | From Day 1 until the final study visit for each subject (approximately 12 months) |
| Number of subjects with VWF or FVIII inhibitors | At screening, Day 1 and approximately Months 3, 6, 9 and 12, for each subject. |
| Haemostatic efficacy - prophylaxis | Subject's and investigator's assessment of haemostatic efficacy of Voncento as prophylaxis therapy. Assessments of haemostatic efficacy will be based on a grading scale with outcomes of excellent, good, moderate, none. | Approximately every month (subject assessment) and every 3 months (Investigator assessment) for the duration of the subject's participation in the study (approximately 12 months). |
| Duisburg |
| Germany |
| Study Site | Frankfurt | Germany |
| Study Site | Athens | Greece |
| Study Site | Krakow | Poland |
| Study Site | Rzeszów | Poland |
| Study Site | Wroclaw | Poland |
| Study Site 14 | London | United Kingdom |
| Study Site 40 | London | United Kingdom |
| Study Site 42 | London | United Kingdom |
| Study Site 47 | London | United Kingdom |
| Study Site 8 | London | United Kingdom |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |