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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04350606 | A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia | PHASE3 | COMPLETED | 3 | — | — | Jul 25, 2020 | Apr 19, 2021 | Apr 27, 2022 | 3 | Japan |
Hematologic response was considered to be "effective" when 2 or more of the following criteria were met: absolute neutrophil count greater than or equal to (\>=) 500 per microliters, platelet count \>=20,000 per microliters and reticulocyte count \>=60,000 per microliters was observed. In this outcome measure, number of participants with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not considered as fulfilling response criteria.
| Arm | Type | Description |
|---|---|---|
| PF-006462700 group | EXPERIMENTAL | All enrolled participants will be administrated PF-006462700. |
| Name | Type | Description |
|---|---|---|
| PF-06462700 | BIOLOGICAL | PF-06462700 is classified as an immunosuppressant/ immunosuppressive agent. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric immunoglobulin G (IgG), from hyperimmune serum of horses that are immunized with human thymus lymphocytes. |
Inclusion Criteria: * Male or female participants between the ages of 2 years and more, inclusive, at Visit 1 (Screening). * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Have a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | — | Anti-human thymocyte immunoglobulin, equine |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |