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Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Sponsor: CSL Behring
Summary
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.
Official title: A Phase 2, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-07-10
Completion Date
2027-08-07
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
CSL889
CSL889 is a solution for infusion to be administered by the IV route.
Placebo
Volume and regimen matched to CSL889 will be administered.
Locations (15)
University of California Irvine
Orange, California, United States
Golisano Children's Hospital
Fort Myers, Florida, United States
The Foundation for Sickle Cell Disease
Hollywood, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hacettepe Universitesi
Ankara, Turkey (Türkiye)
Istanbul Universitesi
Istanbul, Turkey (Türkiye)
Özel Acibadem Adana Hastanesi
Seyhan, Turkey (Türkiye)