The INTERCEPT® Blood System for Red Blood Cells Clinical Development Program
Red blood cell (RBC) components, the most frequently transfused blood component, are typically used in patients to offset blood loss after trauma and during surgery. Cerus is developing the INTERCEPT Blood System for RBCs to reduce the risk of transfusion-transmitted pathogens, as well as decrease the potential for adverse transfusion reactions. US studies are funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.*
The INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS) Study, is a Phase 3 study designed to evaluate the safety and efficacy of INTERCEPT-treated RBCs compared to conventional RBCs in regions impacted by the Zika virus.
RedeS is a two-stage study. The first stage of the trial is a double-blind, controlled, parallel group trial where 600 adult patients will be randomized to receive up to 28 days of transfusion support with INTERCEPT-treated or conventional RBCs, with a primary endpoint of hemoglobin increment following transfusion. In a second stage, up to 20,000 patients would receive RBC transfusion support with up to 50,000 RBC units in an open-label, single-arm treatment use study. The objective of the second stage is to provide early access to the INTERCEPT Blood System for RBCs in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus, or future similar mosquito-borne epidemics.
The study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures (ReCePI) is a US Phase 3 trial designed to evaluate the efficacy and safety of INTERCEPT RBCs in patients requiring transfusion for acute blood loss during complex cardiac surgery.
ReCePI is a randomized, double-blinded, controlled, parallel group, non-inferiority study in which a total of 600 patients will be randomized to receive transfusion support with INTERCEPT-treated or with conventional RBCs. The primary efficacy endpoint is the proportion of patients experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels.
PIPER Surveillance Study
To further extend the safety profile of INTERCEPT Platelets, Cerus is executing a post-marketing active surveillance study, or the Phase IV INTERCEPT Platelets Entering Routine use (PIPER) Study. PIPER is a prospective, open-label study designed to evaluate the transfusion of conventional and INTERCEPT treated platelets in hematology/oncology patients, including those undergoing hematopoietic stem cell transplant, who are expected to require one or more platelet component transfusions.
PIPER will evaluate of the frequency of assisted mechanical ventilation required to treat severe pulmonary complications, a common clinical concern in transfusion medicine as it relates to repeated platelet transfusions in patient populations at risk for pulmonary complications, such as hematology/oncology patients. To extend further the safety profile of INTERCEPT platelets, Cerus is executing a post-marketing active surveillance study, or the Phase IV INTERCEPT Platelets Entering Routine use (PIPER) Study.
INTERCEPT Blood System for Red Blood Cells is not approved for commercial use.
*The INTERCEPT Blood Systems for red blood cell project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No.HHSO100201600009C.