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RECRUITING
NCT06699849
PHASE2

Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

Sponsor: CSL Behring

View on ClinicalTrials.gov

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

BIOLOGICAL

CSL889

CSL889 is a solution for infusion to be administered by the IV route.

DRUG

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)