Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
CSL Behring · NCT06699849
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 70
- US sites recruiting
- 19
- Study start
- July 10, 2025
- Record last updated
- October 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: CSL889; Placebo
Conditions: Sickle Cell Disease Vaso-occlusive Crisis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Univ. of California, San Francisco Health Care
Oakland, CA 94609
University of California Irvine
Orange, CA 92868
Site contact: Use Central Contact
Medstar Washington Hospital Center
Washington D.C., DC 20010
Golisano Children's Hospital
Fort Myers, FL 33908
Site contact: Use Central Contact
The Foundation for Sickle Cell Disease
Hollywood, FL 33023-6703
Site contact: Use Central Contact
Arthur M. Blank Hospital-Children's Healthcare of Atlanta
Atlanta, GA 30329
University of Illinois at Chicago
Chicago, IL 60612
University of Louisville Hospital
Louisville, KY 40202
University of Maryland
Baltimore, MD 21201
Site contact: USE CENTRAL Contact
Detroit Medical Center
Detroit, MI 48201
Henry Ford Health System
Detroit, MI 48202
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St. Louis Children's Hospital
St Louis, MO 63110
Mount Sinai Medical Center
New York, NY 10029
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Jacobi Medical Center
The Bronx, NY 10461
Site contact: Central Contact
East Carolina University
Greenville, NC 27834
University of Cincinnati
Cincinnati, OH 45267
Site contact: Use Central Contact
The Ohio State University
Columbus, OH 43085
Site contact: USE CENTRAL CONTACT
University of Pittsburgh
Pittsburgh, PA 15224
Hillman Cancer Center
Pittsburgh, PA 15232
Study contacts (from the official record)
- Trial Registration Coordinator · +1 610-878-4697 · clinicaltrials@cslbehring.com