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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02222545 | Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies | PHASE2 | COMPLETED | 58 | — | — | Nov 2, 2014 | Aug 11, 2020 | Aug 28, 2024 | 24 | United States, Belgium +10 |
Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs.
Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status
| Arm | Type | Description |
|---|---|---|
| OMS721 low dose | EXPERIMENTAL | Administration of OMS721 at a low dose |
| OMS721 medium dose | EXPERIMENTAL | Administration of OMS721 at a medium dose |
| OMS721 high dose | EXPERIMENTAL | Administration of OMS721 at a high dose |
| Name | Type | Description |
|---|---|---|
| OMS721 | BIOLOGICAL | - |
Inclusion Criteria: 1. Are at least age 18 at screening (Visit 1) 2. Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP 3. No clinically apparent alternative explanation for thrombocytopenia and anemia Exclusion Criteria: 1. Had eculizumab therapy within three months prior to...