Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INTERCEPT, Control · 1 trial · 1 indication
Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery.
Percentage of patients with any treatment-emergent adverse events (TEAEs) possibly, probably or definitely related to study RBC transfusion through 28 days after the last study transfusion.
Percentage of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT RBCs by the end of study.
| Arm | Type | Description |
|---|---|---|
| INTERCEPT (test) | EXPERIMENTAL | The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician. |
| Conventional (Control) | ACTIVE_COMPARATOR | The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician. |
| Name | Type | Description |
|---|---|---|
| INTERCEPT | DEVICE | Pathogen reduced RBCs |
| Control | DEVICE | Conventional RBCs |
Inclusion Criteria: 1. Age ≥ 11 years of age 2. Weight ≥ 40 kg 3. Scheduled complex cardiac surgery or thoracic aorta surgery. The procedure may be performed either on or off cardiopulmonary bypass machine (CBP or "pump"). For the purposes of this protocol "Repeat procedure" means that the subject ...
INTERCEPT, Control is an investigational blood system being studied for use in patients with anemia, specifically in the context of complex cardiac surgery. It is being evaluated for its efficacy and safety in a Phase 3 clinical trial. The product is developed by Cerus Corporation.
INTERCEPT, Control is developed by Cerus Corporation, a company traded on the stock exchange under the ticker CERS. The product is currently in Phase 3 clinical development for use in anemia patients undergoing complex cardiac surgery.
INTERCEPT, Control is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 3 study has been completed to evaluate its efficacy and safety in patients with anemia undergoing complex cardiac surgery.
INTERCEPT, Control has been studied in one Phase 3 clinical trial with the identifier NCT03459287. This trial, titled 'Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients,' was completed and enrolled 581 participants in the United States.
INTERCEPT, Control is part of the INTERCEPT Blood System, a technology developed by Cerus Corporation. The clinical trial NCT03459287 specifically evaluates the INTERCEPT Blood System for red blood cells in complex cardiac surgery patients, with INTERCEPT, Control serving as the investigational product in this context.