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Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs

Study acronym: Challenge
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Oct 1, 2027 → Sep 30, 2030
See other at-risk trials from Cerus Corporation

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Oct 1, 2026 to Oct 10, 2026
  2. Primary completion pushed from Oct 1, 2027 to Sep 30, 2030 Show 6 more changesShow less
    • Enrollment increased: 10 → 25 participants
    • Start date: Jun 1, 2026 to Oct 1, 2026
    • Study completion pushed from Jan 1, 2028 to Dec 30, 2030
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description revised
  3. Start date: Jan 1, 2026 to Jun 1, 2026
    • Interventions: INTERCEPT RBCs (Device) to 30-40 mL of INTERCEPT RBCs (Device), ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs (Device)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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/or 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). The 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
Trial Details
NCT Number NCT07152379
Lead Sponsor Cerus Corporation
Conditions
(from sponsor)		 Transfusion Reaction, Hemolytic
Related terms Transfusion Reaction
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov