RedeS Phase 3 Red Blood Cell Study (H-41854)

A Randomized, Double-Blind, Controlled, Parallel Group Study With the INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS Study) and Treatment Use Open-Label Extension Study

Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult patients who require RBC transfusion support.

Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus (ZIKV), and the risk of asymptomatic infection among qualified blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV, the intent of the study is also to reduce the risk of transfusion-transmitted infections (TTI) in general, including transfusion related sepsis and other emerging or concurrent endemic pathogens (e.g. Dengue and Chikungunya), and to reduce the risk of TA-GVHD.

As part of this treatment use study, additional data will be provided on the safety of INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.