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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: CSL Behring • ClinicalTrials.gov ID: NCT06699849

Registry updated: 2026-10-08
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Description

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.

Interventions

  • CSL889 (Biological)
    CSL889 is a solution for infusion to be administered by the IV route.
  • Placebo (Drug)
    Volume and regimen matched to CSL889 will be administered.

Eligibility criteria

Inclusion Criteria: * At the time of informed consent: * 18 years of age (adults); or * 12 to less than (\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \[IDMC\]) * Diagnosed with SCD (any genotype). * Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids. Exclusion Criteria: * VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid. * Must not have a history of \> 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation. * Serum hemoglobin \< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.

Conditions

Sickle Cell Disease Vaso-occlusive Crisis

Locations

  • Univ. of California, San Francisco Health Care — Oakland, California, United States
  • University of California Irvine — Orange, California, United States
  • Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
  • Golisano Children's Hospital — Fort Myers, Florida, United States
  • The Foundation for Sickle Cell Disease — Hollywood, Florida, United States
  • Arthur M. Blank Hospital-Children's Healthcare of Atlanta — Atlanta, Georgia, United States
  • University of Illinois at Chicago — Chicago, Illinois, United States
  • University of Louisville Hospital — Louisville, Kentucky, United States
  • University of Maryland — Baltimore, Maryland, United States
  • Detroit Medical Center — Detroit, Michigan, United States
  • Henry Ford Health System — Detroit, Michigan, United States
  • St. Louis Children's Hospital — St Louis, Missouri, United States
  • Mount Sinai Medical Center — New York, New York, United States
  • Jacobi Medical Center — The Bronx, New York, United States
  • East Carolina University — Greenville, North Carolina, United States
  • University of Cincinnati — Cincinnati, Ohio, United States
  • The Ohio State University — Columbus, Ohio, United States
  • University of Pittsburgh — Pittsburgh, Pennsylvania, United States
  • Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • Baskent University School of Medicine — Adana, Turkey (Türkiye)
  • Hacettepe Universitesi — Ankara, Turkey (Türkiye)
  • Istanbul Universitesi — Istanbul, Turkey (Türkiye)
  • Medical Park Mersin Hospital — Mezitli-Mersin, Turkey (Türkiye)
  • Özel Acibadem Adana Hastanesi — Seyhan, Turkey (Türkiye)
  • Özel Acibadem Adana Hastanesi — Seyhan/Adana, Turkey (Türkiye)
  • Mersin Universitesi — Yenişehir, Turkey (Türkiye)
  • Royal Liverpool University Hospital — Liverpool, United Kingdom
  • University College London Hospitals NHS Trust — London, United Kingdom
  • Guy's Hospital — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record