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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02203396 | A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia | PHASE2 | COMPLETED | 40 | — | — | Aug 1, 2014 | Sep 1, 2017 | Feb 11, 2026 | 1 | China |
Response will be evaluated at each clinic visit. Complete response (CR) was defined as achieving all three peripheral blood count criteria: (1) Hb level up to the normal range; (2) ANC≥1.5×109/L; (3) PLT≥100×109/L. Partial response (PR) was defined as transfusion independent, no longer meeting criteria for severe disease. Persistence of transfusion requirement or death was evidence of no response (NR).
| Arm | Type | Description |
|---|---|---|
| Severe Aplastic Anemia | EXPERIMENTAL | Drug: rabbit ATG, Cyclosporine, Levamisole |
| Name | Type | Description |
|---|---|---|
| rabbit ATG, Cyclosporine, Levamisole | DRUG | rATG is administered at a dose of 1.97 mg/kg/day for 9 days CSA is administered orally at a dose of 3 mg/kg qod Levamisole is administered orally at a dose of 2.5 mg/kg qod. The CSA and LMS is designed to alternately every other day. |
Inclusion Criteria: * Newly diagnosed SAA (according to the standard criteria) 1. Bone marrow cellularity less than 30% (excluding lymphocytes) 2. At least two of the following: Absolute neutrophil count less than 500/ uL; Platelet count less than 20,000/ uL; Absolute reticulocyte count less t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | — | Anti-human thymocyte immunoglobulin, equine |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |