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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01711346 | A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells | PHASE2 | COMPLETED | 42 | — | — | Oct 1, 2012 | Nov 1, 2014 | Dec 16, 2015 | 2 | United States |
24 hour post-infusion recovery of autologous RBCs stored for 35 days (assessed using the Food and Drug Administration (FDA)) criteria for evaluation of in vivo RBC studies)
Incidence of antibody specific to S 303 treated RBCs
| Arm | Type | Description |
|---|---|---|
| S303 Red Blood Cells (RBCs) | EXPERIMENTAL | Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs). |
| Conventional, Untreated Red Blood Cells (RBCs) | ACTIVE_COMPARATOR | Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs). |
| Name | Type | Description |
|---|---|---|
| S303 Red Blood Cells (RBCs) | BIOLOGICAL | Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL. |
| Conventional, untreated Red Blood Cells (RBCs) | BIOLOGICAL | Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL. |
Inclusion Criteria: * Age at least 18 years, of either gender * Normal health status (as determined by the Investigator review of medical history and blood donor physical exam) * Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), m...