Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as S-303 Treated Red Blood Cells (RBCs)
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 being developed for thalassemia major in patients who require chronic red blood cell transfusion. It is a pathogen-reduced red blood cell product studied as an alternative transfusion option for this patient population. The program is in Phase 3 development.
S-303 Treated Red Blood Cells is developed by Cerus Corporation, which trades on the Nasdaq under the ticker CERS. Cerus is the sponsor of the clinical program evaluating this pathogen-reduced red blood cell product in patients with thalassemia major.
S-303 Treated Red Blood Cells is in Phase 3 development. The program has one completed Phase 3 trial and no active trials. It is an investigational product and has not been approved by the FDA for any indication.
S-303 Treated Red Blood Cells has been studied in one Phase 3 trial, NCT01740531, titled a study to evaluate efficacy and safety of S303 treated red blood cells in subjects with thalassemia major requiring chronic RBC transfusion. The trial is completed, enrolled 86 participants, and was conducted in Italy and Turkey.
Yes. S-303 Treated Red Blood Cells (RBCs) is the same product as S-303 Treated Red Blood Cells. RBCs is simply shorthand for red blood cells, so both names refer to the same Cerus Corporation pathogen-reduced red blood cell product in Phase 3 development for thalassemia major.
The completed Phase 3 trial NCT01740531 was randomized, double-blind, and active-controlled, enrolling 86 participants with thalassemia major who required chronic red blood cell transfusion. Participants were 10 years of age or older, and the study included sites in Italy and Turkey.