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Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 26 → 30 locations Start date: Aug 7, 2025 to Jul 10, 2025 · Eligibility criteria expanded, about 8 words Show 2 more changesShow less
    • Start date: Aug 7, 2025 to Jul 10, 2025
    • Eligibility criteria expanded, about 8 words
  2. Trial sites expanded: 19 → 26 locationsv24
  3. Study sites: 17 to 19v23
  4. Start date: Jul 10, 2025 to Aug 7, 2025 Study sites revised (17)v22 Show 1 more changeShow less
    • Study sites revised (17)

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion pushed from Aug 7, 2027 to Oct 22, 2027 Study sites: 15 to 17v21 Show 1 more changeShow less
    • Study sites: 15 to 17
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 14 to 15v20
  2. Study sites: 13 to 14v19
  3. Trial status: Active, Not Recruiting to Recruiting Study sites: 12 to 13v18 Show 1 more changeShow less
    • Study sites: 12 to 13
  4. Study sites: 17 to 12v17
  5. Phase: Phase 2/3 to Phase 2 Enrollment target: 260 to 70 · Primary and study completion dates: Apr 4, 2028 to Aug 7, 2027 · Eligibility criteria shortened, about 19 words · 2 morev16 Show 5 more changesShow less
    • Enrollment target: 260 to 70
    • Primary and study completion dates: Apr 4, 2028 to Aug 7, 2027
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints: 17 to 21
    • Study arms: 6 to 3

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Recruiting to Active, Not Recruiting Site details revised at 17 of 17 sitesv15 Show 1 more changeShow less
    • Site details revised at 17 of 17 sites
  7. Study sites: 16 to 17v14
  8. Study sites: 13 to 16v13
  9. Study sites: 12 to 13v12
  10. Study sites: 9 to 12v11
  11. Site details revised at 1 of 9 sitesv10
  12. Study sites: 5 to 9v9
  13. Start date changed from estimate of Jul 11, 2025 to Jul 10, 2025v8
  14. Study sites: 4 to 5v7
  15. Start date: Feb 14, 2025 to Jul 11, 2025v6
  16. Study sites: 1 to 4v5
  17. Re-verified, no change to tracked fieldsv4
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Feb 10, 2025 to Feb 14, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 10, 2025 to Feb 14, 2025
  19. 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.
This is a phase 2, randomized, multiple-dose, placebo-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to evaluate the safety and tolerability of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.
Trial Details
NCT Number NCT06699849
Lead Sponsor CSL Behring
Conditions Sickle Cell Disease Vaso-occlusive Crisis
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov