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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00471848 | Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia | PHASE2 | COMPLETED | 35 | — | — | Aug 1, 2008 | Feb 1, 2013 | May 12, 2026 | 14 | France, Germany +4 |
Complete Response (CR) defined as: Haemoglobin normal for age and gender, neutrophils \> 1.5 x 10E9/l, platelets \> 150 x 10E9/l. Partial Response (PR) defined as: * transfusion independence (if previously dependent) or * doubling or normalisation of at least one cell line or * increase of baseline haemoglobin of \> 3 g/dl (if initially \<6) + neutrophils of \> 0.5 x 10E9/l + platelets of \> 20 x 10E9/l (if initially \< 20) No Response (MR) is defined as: worse or not meeting criteria above
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Antithymocyte globulin with cyclosporin in first line treatment of patients with acquired severe aplastic anaemia and patients with non-severe aplastic anaemia who are transfusion dependent |
| Name | Type | Description |
|---|---|---|
| rabbit antithymocyte globulin | DRUG | 1.5 vials/10kg daily for 5 days |
Inclusion Criteria: 1. Must fulfil definition of aplastic anaemia: There must be at least two of the following: * haemoglobin \< 10g/dl * platelet count \< 50 x 109/l * neutrophil count \< 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy SAA as defined by a hypocel...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | — | Anti-human thymocyte immunoglobulin, equine |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |