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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California Irvine
NOT_YET_RECRUITING
Orange
Florida
Golisano Children's Hospital
RECRUITING
Fort Myers
The Foundation for Sickle Cell Disease
RECRUITING
Hollywood
Maryland
University of Maryland
RECRUITING
Baltimore
Michigan
Detroit Medical Center
RECRUITING
Detroit
Henry Ford Health System
RECRUITING
Detroit
New York
Mount Sinai Medical Center
RECRUITING
New York
Albert Einstein College of Medicine
WITHDRAWN
The Bronx
Jacobi Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati
RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Pennsylvania
Hillman Cancer Center
RECRUITING
Pittsburgh
University of Pittsburgh
RECRUITING
Pittsburgh
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Turkey
Hacettepe Universitesi
NOT_YET_RECRUITING
Ankara
Istanbul Universitesi
NOT_YET_RECRUITING
Istanbul
Özel Acibadem Adana Hastanesi
NOT_YET_RECRUITING
Seyhan
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+1 610-878-4697
Time Frame
Start Date:2025-07-10
Estimated Completion Date:2027-10-22
Participants
Target number of participants:70
Treatments
Experimental: CSL889 Regimen 1
Participants in this arm will receive CSL889 as per regimen 1.
Experimental: CSL889 Regimen 2
Participants in this arm will receive CSL889 as per regimen 2.
Placebo_comparator: Placebo
Participants in this arm will receive placebo matching to CSL889 regimen.