[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594130":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":69,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Cerus Corporation","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Test RBCs will be prepared with the INTERCEPT Blood System for RBCs","EXPERIMENTAL","One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs.",[13,14],"Device: INTERCEPT Blood System for RBCs","Other: Infusion of autologous radiolabeled RBCs",{"label":16,"type":10,"description":17,"interventionNames":18},"Control RBC components will be prepared according to the site standard operating procedures","One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","INTERCEPT Blood System for RBCs","RBCs treated with the INTERCEPT Blood System for RBCs",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Infusion of autologous radiolabeled RBCs","Subject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Margaret Hennig, Ph.D.","CONTACT","925-288-6178","mhennig@cerus.com",[38,55],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hoxworth Blood Center","NOT_YET_RECRUITING","Cincinnati","Ohio","45267","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-84.51439,39.12711,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":25,"phoneExt":25,"email":25},"Neeta Rugg",{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"American Red Cross Research Laboratory","RECRUITING","Norfolk","Virginia","23510",{"type":47,"coordinates":62},[63,64],-76.28522,36.84681,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":25,"phoneExt":25,"email":25},"Bethany Brown, Ph.D., MSCS",{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100594130","phase-2-a-recovery-and-lifespan-study-using-intercept-red-blood-cells-prepared-using-the-intercept-blood-system-for-rbcs-with-as-1-100594130",false,"NCT07015437","A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1","A Randomized, Controlled, Single-Blind, 2-Arm Parallel Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1","Inclusion Criteria:\n\n* Age ≥18 years\n* Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.\n* Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:\n* Meeting allogeneic deferral criteria due to travel, tattoos\u002Fpiercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.\n* Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease\n* History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)\n* Positive DAT or IAT at study entry\n* Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days\n* Treatment with any medication known to affect RBC viability\n* Pregnant or nursing females\n* Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days\n* Less than three months from receiving an infusion of a radiolabeled blood component.\n* Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.\n* Non study blood component donation throughout the study\n* Preexisting antibody specific to INTERCEPT RBCs\n* History of known hypersensitivity to chromium or technetium",true,"ALL","18 Years",{"count":82,"type":83},70,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.",[89],"Healthy Subjects",[91,92,93,94,95,96,97,98,99,100],"INTERCEPT","Red Blood Cells","RBC","Pathogen Inactivation","Pathogen reduction","Cerus","Survival","Radiolabel","Autologous","Recovery","2025-10-13",{"date":103,"type":104},"2025-10-15","ACTUAL",{"date":106,"type":104},"2025-09-19",{"date":108,"type":83},"2026-10-15",{"name":5,"class":6},2]