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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00816660 | Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease | PHASE1 | COMPLETED | 32 | — | — | Dec 1, 2008 | Aug 31, 2010 | May 3, 2021 | 25 | United States, Austria +4 |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII) | BIOLOGICAL | Single dose, dose escalation, various cohorts |
| Marketed plasma-derived VWF/FVIII concentrate | BIOLOGICAL | Cross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate |
Inclusion Criteria: * Subject has voluntarily given written informed consent (before conduct of any study-related procedures) * The subject has hereditary type 3 VWD (\<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo \<= 10% and FVIII:C \<20%) * The subject has a medical history of at lea...