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INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections

Study acronym: RedeS
StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Trial completed Show 8 more changesShow less
    • Primary completion date changed from estimate of Jul 31, 2026 to Apr 29, 2026
    • Study completion date changed from estimate of Dec 30, 2026 to Jul 6, 2026
    • Start date: May 11, 2017 to May 10, 2017
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description expanded, about 22 words
    • Site details revised at 4 of 16 sites
    • Publications: details revised at 1 of 1 entry
  2. Eligibility criteria shortened, about 10 words
    • Study description shortened, about 72 words
    v17
  3. Primary completion date: Oct 31, 2025 to Jul 31, 2026v16 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 800 to confirmed 692
    • Study sites: 12 to 16
    • Study completion date: Jan 30, 2026 to Dec 30, 2026
  4. Primary completion date: Dec 31, 2022 to Oct 31, 2025
    • Study sites: 9 to 12
    • Study completion date: Jan 30, 2023 to Jan 30, 2026
    • Study description revised
    v15
  5. Primary completion date: Dec 31, 2021 to Dec 31, 2022v14 Show 6 more changesShow less
    • Enrollment target: 600 to 800
    • Study completion date: Jan 30, 2022 to Jan 30, 2023
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 5 to 8
    • Study description expanded, about 334 words
    • Site details revised at 5 of 9 sites
Show 12 earlier versionsHide 12 earlier versions
  1. Primary endpoints revised (3)v13 Show 4 more changesShow less
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 204 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 197 words
  2. Primary completion date: Jun 30, 2020 to Dec 31, 2021
    • Study completion date: Dec 30, 2020 to Jan 30, 2022
    v12
  3. Site details revised at 1 of 8 sitesv11
  4. Site contacts updated at 1 of 8 sites
    • Study title shortened, about 4 words
    v10
  5. Primary completion date: Nov 30, 2018 to Jun 30, 2020
    • Study sites: 7 to 8
    • Study completion date: Mar 30, 2019 to Dec 30, 2020
    v9
  6. Site details revised at 1 of 7 sitesv8
  7. Study sites: 3 to 7v7
  8. Secondary endpoints: details revised at 1 of 5 entriesv6
  9. Site details revised at 1 of 3 sitesv5
  10. Site details revised at 1 of 3 sitesv4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 6, 2017 to May 11, 2017
    v3
  12. Re-verified, no change to tracked fieldsv2
  1. 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.
To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in patients who require RBC transfusion support.
Trial Details
NCT Number NCT03037164
Lead Sponsor Cerus Corporation
Conditions
(from sponsor)		 Anemia
Related terms Anemia, Zika Virus Infection
Enrollment 692 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov