Table 4.

Summary of completed clinical studies with INTERCEPT RBCs

Study161, 162, 163	Population	Intervention	Study design	Comparison	Outcome
CLI 00062	28 enrolled, 26 evaluable, healthy subjects	Compare survival and recovery of autologous INTERCEPT RBCs to conventional RBCs (prototype set)	Single‐blinded, randomized crossover, controlled radiolabeled autologous RBC	Single transfusion ~10 mL of 51Cr‐labeled test or control RBCs (35‐day storage)	RBCs prepared using the INTERCEPT PI process were physiologically and metabolically suitable for transfusion after 35 days of storage, met the FDA guidance criteria for 24‐hour recovery, and did not induce antibody formation.
CLI 00073	42 enrolled, 26 evaluable, healthy subjects	Compare survival and recovery of autologous INTERCEPT RBCs to conventional RBCs (final set)	Single‐blinded, randomized crossover, controlled, radiolabeled autologous RBC	Single transfusion 10‐30 mL of autologous 51Cr‐labeled test or control RBCs (35‐day storage)	RBCs met the FDA criteria for posttransfusion RBC recovery 24 hr after transfusion. The mean life span and median life span (T50) of autologous RBCs after storage for 35 days were shorter for test RBCs compared to control RBCs, but within the published reference range, and the AUCs of test and control were not different.
CLI 00070 (STARS)	87 randomized, 51 evaluable, cardiac surgery patients	Assess the in vitro characteristics of INTERCEPT RBCs; assess the clinical safety and efficacy of INTERCEPT RBCs in transfusion support for acute anemia	Randomized, controlled, double‐blinded, parallel design, noninferiority	INTERCEPT or conventional RBCs for up to 7 days during and after surgery	The mean postproduction Hb content per component was 53.6 ± 5.6 g/component in the test and 56.3 ± 6.0 g/component in the control groups. Equivalence was declared since the 95% CI for the mean treatment difference was within the a priori defined margins (±5 g/component). INTERCEPT RBC components met EDQM guidelines for Hb content, hematocrit, and hemolysis. The safety profile of INTERCEPT RBCs was comparable to conventional RBCs.
CLI 00076 (SPARC)	86 randomized, 81 evaluable, transfusion‐dependent thalassemia patients	Evaluate the efficacy and safety of INTERCEPT RBCs in subjects who require chronic transfusion support due to thalassemia major	Randomized, controlled, double blinded, two‐period, crossover, noninferiority	Six transfusion episodes of INTERCEPT or conventional RBC; two wash‐in and four evaluable episodes	Mean Hb consumption (g/kg/day) with INTERCEPT RBCs was not inferior (p < 0.001) to conventional RBCs (0.113 ± 0.04 vs. 0.111 ± 0.04, p = 0.373) by intent‐to‐treat or per‐protocol (0.112 ± 0.04 vs. 0.110 ± 0.03, p = 0.162) analysis. No antibodies specific to INTERCEPT RBCs were detected; there were no substantial differences in transfusion reactions, adverse events, or serious adverse events recorded.