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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01740531 | Study to Evaluate Efficacy and Safety of S303 Treated Red Blood Cells (RBCs)in Subjects With Thalassemia Major Requiring Chronic RBC Transfusion | PHASE3 | COMPLETED | 86 | — | — | Dec 1, 2012 | Dec 31, 2017 | Jul 18, 2018 | 3 | Italy, Turkey (Türkiye) |
Hemoglobin consumption measured as total hemoglobin mass transfused per subject adjusted for average body weight and the number of days during the efficacy evaluation period (adjusted hemoglobin (Hgb) consumption units are g Hgb/kg body weight/day).
Incidence of a treatment-emergent antibody with confirmed specificity to S 303 treated red blood cells (RBC) associated with clinically significant hemolysis
| Arm | Type | Description |
|---|---|---|
| S-303 Treated Red Blood Cells (RBC) | EXPERIMENTAL | Patients will be randomly assigned to the sequence of administration of Test and Control RBCs; eligible patients are randomly assigned to receive Test RBCs followed by Control RBCs or Control RBCs followed by Test RBCs. Each patient will complete both treatment periods. |
| Conventional, untreated Red Blood Cells | ACTIVE_COMPARATOR | Patients will be randomly assigned to the sequence of administration of Test and Control RBCs; eligible patients are randomly assigned to receive Test RBCs followed by Control RBCs or Control RBCs followed by Test RBCs. Each patient will complete both treatment periods. |
| Name | Type | Description |
|---|---|---|
| S-303 Treated Red Blood Cells (RBCs) | BIOLOGICAL | - |
| Conventional, untreated Red Blood Cells | BIOLOGICAL | - |
Inclusion Criteria: * Age ≥10 years, of either gender * Diagnosed with thalassemia major and currently participating in a chronic transfusion program * At least a one year history of chronic RBC transfusion support with a stable transfusion requirement (per treating physician) * Intervals of at lea...