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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01716923 | Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia | PHASE3 | COMPLETED | 81 | — | — | Apr 1, 2013 | Oct 1, 2014 | Aug 26, 2015 | 2 | Germany |
The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups
The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.
| Arm | Type | Description |
|---|---|---|
| S-303 Treated Red Blood Cells | EXPERIMENTAL | Patients receive S-303 treated red blood cells (RBCs). |
| Conventional, untreated Red Blood Cells | ACTIVE_COMPARATOR | Patients receive conventional, untreated red blood cells (RBCs). |
| Name | Type | Description |
|---|---|---|
| S-303 Red Blood Cells (RBCs) - Test | BIOLOGICAL | - |
| Conventional, untreated red blood cells (RBCs) - Control | BIOLOGICAL | - |
Inclusion Criteria: 1. Age ≥18 years, of either gender. 2. Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee) 3. Must be readily available by telephone 4. Must provide an informed consent for study participation and have signed an...