Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Start Date
8/7/2025
Completion Date
10/22/2027
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.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
CSL889
Placebo
Conditions
Locations
Univ. of California, San Francisco Health Care
Oakland, California 94609
United States
University of California Irvine
Orange, California 92868
United States
Golisano Children's Hospital
Fort Myers, Florida 33908
United States
The Foundation for Sickle Cell Disease
Hollywood, Florida 33023-6703
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
University of Maryland
Baltimore, Maryland 21201
United States
Detroit Medical Center
Detroit, Michigan 48201
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Mount Sinai Medical Center
New York, New York 10029
United States
Jacobi Medical Center
The Bronx, New York 10461
United States
East Carolina University
Greenville, North Carolina 27834
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States
The Ohio State University
Columbus, Ohio 43085
United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15224
United States
Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Hacettepe Universitesi
Ankara, 06230
Turkey (Türkiye)
Istanbul Universitesi
Istanbul, 34093
Turkey (Türkiye)
Özel Acibadem Adana Hastanesi
Seyhan, 01130
Turkey (Türkiye)