[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604658":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":30,"collaborators":26,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":26,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":26},{"fullName":5,"class":6},"Cerus Corporation","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects with Antibodies to INTERCEPT RBC Either Naturally Acquired or Treatment Emergent","EXPERIMENTAL","Test subjects will be selected from the pool of subjects who have documented antibodies to INTERCEPT RBC either naturally acquired (e.g., detected during a pre-transfusion enrollment screening process) or treatment-emergent following an INTERCEPT RBC transfusion. Eligible subjects may have been enrolled in either the Test or Control arms of prior studies; subjects whose randomization status is still blinded may also be enrolled in this study if they have completed the study requirements of the prior study and \\>120 days have elapsed since exposure to a study RBC product.",[13,14],"Device: 30-40 mL of INTERCEPT RBCs","Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs",{"label":16,"type":17,"description":18,"interventionNames":19},"Subjects with history of transfusion without INTERCEPT RBC antibodies","ACTIVE_COMPARATOR","Control subjects will be identified by participating study sites as individuals with a history of allogeneic transfusion(s) without a history of or currently demonstrable INTERCEPT RBC antibodies.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","30-40 mL of INTERCEPT RBCs","Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or\n\n\\~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.",[9,16],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs",[9,16],{"type":31,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100604658","phase-2-challenge-transfusion-of-intercept-pathogen-reduced-red-blood-cells-rbcs-in-subjects-with-or-without-pre-existing-antibodies-to-intercept-rbcs-100604658",false,"NCT07152379","Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs","An Open-label, Controlled Phase 2 Study Assessing a Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs","Challenge","Inclusion Criteria:\n\n* Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB).\n* Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC.\n* Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs.\n* History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated).\n* \\>120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion.\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period.\n* Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study.\n* Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion.\n* Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity\u002Fmortality due to hemolysis or the medical management of acute hemolysis.\n* Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins)\n* History of or development of a drug-associated RBC antibody not associated with INTERCEPT RBCs.\n* Congenital or acquired immunodeficiency judged by the Investigator to potentially impact the humoral immune response.\n* Immunosuppressive therapy within 1 month prior to enrollment or during the study period, including steroids and intravenous immunoglobulin.\n* Current or historical RBC alloantibodies that are judged by the Investigator to prevent selection of antigen-negative RBCs for transfusion.\n* History of immunoglobulin A (IgA) deficiency, severe allergic reaction to blood product(s), or clinical requirement to receive washed cellular products.\n* History of warm autoantibody with hemolysis.\n* Subjects who are pregnant, or biologically able to become pregnant and unwilling to remain on medically accepted contraception during this study.","ALL","4 Years",{"count":43,"type":44},10,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and\u002For evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).\n\nThe study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs",[50],"Transfusion Reaction, Hemolytic",[52],"INTERCEPT, red blood cells, antibody","NOT_YET_RECRUITING","2026-06-04",{"date":56,"type":57},"2026-06-08","ACTUAL",{"date":59,"type":44},"2026-06-01",{"date":61,"type":44},"2028-01-01",{"name":5,"class":6}]