Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03879135 | A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD) | PHASE3 | COMPLETED | 38 | — | — | Apr 1, 2019 | Jan 30, 2025 | Sep 3, 2025 | 33 | United States, Austria +7 |
sABR was derived as \[number of treated bleeds\] / \[duration in years\]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during the first 12 months of prophylactic treatment with rVWF (vonicog alfa) was reported.
| Arm | Type | Description |
|---|---|---|
| On-Demand | EXPERIMENTAL | Participants will receive recombinant von Willebrand factor (rVWF) (with or without ADVATE). |
| Prophylaxis | EXPERIMENTAL | Participants will receive recombinant von Willebrand factor (rVWF). |
| Name | Type | Description |
|---|---|---|
| rVWF | BIOLOGICAL | Recombinant von Willebrand factor |
| rFVIII | BIOLOGICAL | Recombinant Factor VIII |
Inclusion Criteria: The participant will not be considered eligible for the study without meeting all of the criteria below. Participants who have completed Study 071301 or Study 071102 (or participants who have completed the surgery arm treatment in Study 071102 and want to continue to receive on...