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NCT06699849RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
70 (estimated)
First submitted
19 Nov 2024
Start date
10 Jul 2025
Primary completion date
22 Oct 2027
Lead sponsor
CSL Behring
NCT number
NCT06699849
EU CT number
2024-513440-29-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 70
  • From 10 Jul 2025 to the primary completion date, 22 Oct 2027
  • 58 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Must not have a history of \> 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.

Lab values

  • 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.

Other

  • VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid.

Who the study is looking for

  • 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Erasme
Coordinator of this site? Confirm its status
AnderlechtBelgiumCompleted
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumCompleted
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumCompleted
Centre Hospitalier Regional de la Citadelle
Coordinator of this site? Confirm its status
LiègeBelgiumCompleted
Medical Center- University of Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Assistance Publique Hopitaux De Paris
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BobignyFranceCompleted
Pellegrin Hospital
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BordeauxFranceCompleted
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Hospices Civils De Lyon
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Lyon Cedex 03FranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceCompleted
Royal Liverpool University Hospital
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LiverpoolUnited KingdomRecruiting
Guy's Hospital
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LondonUnited KingdomRecruiting
University College London Hospitals NHS Trust
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LondonUnited KingdomRecruiting
Laiko General Hospital of Athens
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AthensGreeceCompleted
IRCCS Istituto Giannina Gaslini
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GenoaItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Azienda Ospedaliera di Padova
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PadovaItalyCompleted
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyCompleted
Ospedale Pediatrico Bambino Gesù
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RomeItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
Amsterdam UMC Stichting
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AmsterdamNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Arthur M Blank Hospital - Children's Healthcare of Atlanta
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
University of Maryland
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BaltimoreUnited StatesRecruiting
University of Illinois at Chicago
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ChicagoUnited StatesRecruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
The Ohio State University
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ColumbusUnited StatesRecruiting
Henry Ford Health System
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DetroitUnited StatesRecruiting
Detroit Medical Center
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DetroitUnited StatesRecruiting
Golisano Children's Hospital
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Fort MyersUnited StatesRecruiting
East Carolina University
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
The Foundation for Sickle Cell Disease
Coordinator of this site? Confirm its status
HollywoodUnited StatesRecruiting
University of Louisville Hospital
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LouisvilleUnited StatesRecruiting
Mount SInai Medical Center
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New YorkUnited StatesRecruiting
Univ. of California, San Francisco Health Care
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OaklandUnited StatesRecruiting
University of California Irvine
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OrangeUnited StatesRecruiting
University of Pittsburgh
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PittsburghUnited StatesRecruiting
Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Virginia Commonwealth University
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RichmondUnited StatesWithdrawn
St. Louis Children's Hospital
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St LouisUnited StatesRecruiting
Jacobi Medical Center
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The BronxUnited StatesRecruiting
MedStar Washington Hospital Center
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Washington D.C.United StatesRecruiting
Baskent University School of Medicine
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AdanaTurkey (Türkiye)Recruiting
Hacettepe Üniversitesi
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AnkaraTurkey (Türkiye)Recruiting
Istanbul Universitesi
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IstanbulTurkey (Türkiye)Not yet recruiting
Medical Park Mersin Hospital
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Mezitli-MersinTurkey (Türkiye)Recruiting
Özel Acibadem Adana Hastanesi
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SeyhanTurkey (Türkiye)Recruiting
Özel Acibadem Adana Hastanesi
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Seyhan/AdanaTurkey (Türkiye)Recruiting
Mersin Universitesi
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YenişehirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.