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MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eqwilate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eqwilate | Biological | Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemostatic Effectiveness of On-demand Treatment | Haemostatic Effectiveness of On-demand Treatment (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode. | 12 months |
| Haemostatic Effectiveness of Perioperative Prophylaxis | Haemostatic Effectiveness of Perioperative Prophylaxis (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode. | 12 months |
| Occurrence of Bleeding Episodes During Follow-Up | Occurrence of Bleeding Episodes During Follow-Up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| FVIII Levels | Clotting factor VII levels in blood | 12 months |
| Productivity Loss | Days lost from school or work | 12 months |
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Inclusion Criteria:
The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. Patients will be of any VWD type, previously treated or untreated.
Exclusion Criteria:
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The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen Study Site | Caen | 14033 | France | |||
| Clamart 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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| Volume of Blood loss | Volume of Blood loss | up to 1 week |
| Immunogenicity Presence of inhibitors against VWF | Presence of inhibitors against VWF found via blood draw analysis | 12 months |
| Clamart |
| 92141 |
| France |
| Paris Study Site - Lariboisiere | Paris | 75010 | France |
| Paris Study Site - Necker | Paris | 75015 | France |
| Rennes Study Site | Rennes | 35033 | France |
| Rouen Study Site | Rouen | 76031 | France |
| Saint Denis Study Site - Pediatrie | Saint-Denis | 97405 | France |
| Saint Denis Study Site | Saint-Denis | 97405 | France |
| Saint-Etienne Study Site | Saint-Etienne | 42055 | France |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |