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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02099747 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | PHASE3 | COMPLETED | 202 | — | — | Jul 1, 2015 | Dec 1, 2020 | Apr 24, 2026 | 29 | France, Italy +4 |
The primary objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response in untreated AA patient.
| Arm | Type | Description |
|---|---|---|
| hATG + CsA | ACTIVE_COMPARATOR | Control Arm |
| hATG + CsA + Eltrombopag | EXPERIMENTAL | Experimental |
| Name | Type | Description |
|---|---|---|
| hATG | DRUG | - |
| CsA | DRUG | - |
| Eltrombopag | DRUG | - |
Inclusion Criteria: 1. Diagnosis of severe or very severe aplastic anemia, defined by \[29\]: * At least two of the following: * Absolute neutrophil counts \<0.5 x 109/L (severe) or \<0.2 x 109/L (very severe) * Platelet counts \<20 x 109/L * Reticulocyte counts \<60 x 109/L ...