INTERCEPT Safety Evaluation on Whole Blood

The pathogen reduction system for whole blood using amustaline (S-303) and glutathione (GSH) hast a potential to decrease transfusion-transmitted infection. There is a scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to assess the safety of whole blood treated with amustaline and glutathione and transfused in patients with anemia. This is a first-in-human-subjects study. Whole blood (WB) products treated with the amustaline (S-303) and glutathione (GSH) pathogen reduction technology have not been evaluated in human beings. However, red blood cells concentrates treated with amustaline and GSH have been evaluated in multiple clinical studies. The study described in this protocol is a randomized, controlled, open-label Phase I clinical trial. 20 patients will be randomized into either the Test or Control arm in a ratio of 1:1. 10 patients assigned to the Test arm will receive one amustaline/GSH treated whole blood product. 10 patients assigned to the Control arm will receive the Standard of Care (SOC), either one red blood cell (RBC) component or one whole blood product.