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A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 30, 2026 → Dec 15, 2026
See other at-risk trials from Cerus Corporation

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 70 → 120 participants Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary completion pushed from Jul 30, 2026 to Dec 15, 2026
    • Study completion pushed from Oct 15, 2026 to Feb 13, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 15, 2025 to Sep 19, 2025
    • Site details revised at 2 of 2 sites
    v3
  3. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07015437
Lead Sponsor Cerus Corporation
Conditions
(from sponsor)		 Healthy Subjects
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov