Actively Recruiting
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Led by CSL Behring · Updated on 2026-05-14
70
Participants Needed
19
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older, or adolescents aged 12 to less than 18 years when approved
- Diagnosed with sickle cell disease of any genotype
- Presenting with a new acute vaso-occlusive crisis requiring parenteral opioid treatment
You will not qualify if you...
- Vaso-occlusive crisis pain started more than 72 hours before first parenteral opioid administration
- History of more than 5 vaso-occlusive crises requiring hospital admission in past 6 months
- Signs or symptoms of acute chest syndrome
- New neurological symptoms suggesting acute stroke or transient ischemic attack
- Any stage of acute kidney injury
- Discharged from inpatient hospital admission for vaso-occlusive crisis or related event within 14 days before current presentation
- Serum hemoglobin less than 6 g/dL
- Serum ferritin 2000 ng/mL or higher
- Not on a stable, well-tolerated regimen of approved medication for sickle cell disease
- Currently taking methadone or buprenorphine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Univ. of California, San Francisco Health Care
Oakland, California, United States, 94609
Actively Recruiting
2
University of California Irvine
Orange, California, United States, 92868
Not Yet Recruiting
3
Golisano Children's Hospital
Fort Myers, Florida, United States, 33908
Actively Recruiting
4
The Foundation for Sickle Cell Disease
Hollywood, Florida, United States, 33023-6703
Actively Recruiting
5
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Detroit Medical Center
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
9
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
10
Jacobi Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
11
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
12
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
13
The Ohio State University
Columbus, Ohio, United States, 43085
Actively Recruiting
14
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
15
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
16
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
17
Hacettepe Universitesi
Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
18
Istanbul Universitesi
Istanbul, Turkey (Türkiye), 34093
Not Yet Recruiting
19
Özel Acibadem Adana Hastanesi
Seyhan, Turkey (Türkiye), 01130
Not Yet Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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