Sickle Cell Disease

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

NCT06699849 | PHASE 2 | INTERVENTIONAL

This study consists of two parts: phase 2 (Part A) and phase 3 (Part B). It is a multicenter study designed to evaluate the safety, effectiveness, 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 assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD, and to evaluate the safety and tolerability of CSL889 in study participants.

17 Sites

260 Participants

ACTIVE NOT RECRUITING

12 Years

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SUBMIT

University of California Irvine

Orange,California,United States,92868

Golisano Children's Hospital

Fort Myers,Florida,United States,33908

The Foundation for Sickle Cell Disease

Hollywood,Florida,United States,33023

University of Maryland

Baltimore,Maryland,United States,21201

Henry Ford Health System

Detroit,Michigan,United States,48202

Mount Sinai Medical Center

New York,New York,United States,10029

Jacobi Medical Center

The Bronx,New York,United States,10461

Albert Einstein College of Medicine

The Bronx,New York,United States,10467

University of Cincinnati

Cincinnati,Ohio,United States,45267

The Ohio State University

Columbus,Ohio,United States,43085

UZ Leuven Centrum voor Moleculaire en Vasculaire Biologie

Leuven,Ohio,Belgium,3000

CHR de la Citadelle

Liège,Ohio,Belgium,4000

AOUI Verona and University of Verona

Verona,Ohio,Italy,37134

Hospital Sant Joan de Du

Barcelona,Ohio,Spain,08950

Hacettepe Universitesi Hacettepe Universitesi Hastaneleri

Ankara,Ohio,Turkey (Türkiye),06230

Istanbul Universitesi Cocuk Sagligi Enstitusu (Institute of Child Health)

Istanbul,Ohio,Turkey (Türkiye),34093

zel Acibadem Adana Hastanesi

Seyhan,Ohio,Turkey (Türkiye),01130

Study Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

* VOC pain onset greater than or equal to (\>=) 72 hours before administration of first parenteral opioid (Part A; may be adjusted for Part B based on prespecified analysis).
* Must not have a history of greater than (\>) 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation.
* Serum hemoglobin \< 6 g/dL, serum ferritin \>= 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.

Additional Studies

Additional studies can be found at ClinicalTrials.gov