Approval Probability
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S-303 Treated Red Blood Cells · 1 trial · 1 indication
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...
S-303 Treated Red Blood Cells is an investigational therapy being studied for use in thalassemia major, a condition requiring chronic red blood cell transfusions. It is a pathogen-reduced red blood cell product designed for transfusion support in this patient population. The therapy is currently in Phase 3 clinical development.
S-303 Treated Red Blood Cells is being developed by Cerus Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol CERS. The company is conducting clinical trials to evaluate the safety and efficacy of this red blood cell product for patients with thalassemia major.
S-303 Treated Red Blood Cells is in Phase 3 clinical development. A Phase 3 study has been completed to evaluate its efficacy and safety in subjects with thalassemia major requiring chronic RBC transfusion. The therapy remains investigational and has not been approved by regulatory authorities.
S-303 Treated Red Blood Cells has one completed Phase 3 clinical trial, registered as NCT01740531. This randomized, double-blind, active-controlled study enrolled 86 participants with thalassemia major across Italy and Turkey. The trial evaluated the efficacy and safety of S-303 treated red blood cells in patients requiring chronic transfusion.
S-303 Treated Red Blood Cells refers to red blood cells treated with the S-303 pathogen inactivation system, which is designed to reduce infectious agents in donated blood. This product is being studied specifically for transfusion support in thalassemia major patients. It is distinct from standard red blood cell products.