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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00102336 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy | PHASE3 | COMPLETED | 62 | — | — | Apr 7, 2005 | Apr 1, 2007 | Nov 8, 2022 | - | — |
| NCT00102323 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy | PHASE3 | COMPLETED | 63 | — | — | Mar 29, 2005 | Mar 1, 2007 | Nov 7, 2022 | - | — |
| Arm | Type | Description |
|---|---|---|
| AMG 531 | EXPERIMENTAL | Active investigational product |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 531 | BIOLOGICAL | Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder. |
| Placebo | DRUG | Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial. |
Inclusion Criteria: * Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F) * Have completed as least 1 prior treatment for ITP (e.g., prednisone) * Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to ...