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
- Diseases
- Sickle cell disease
- 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
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny | France | Completed |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Completed |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Arthur M Blank Hospital - Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Detroit Medical Center Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Golisano Children's Hospital Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| The Foundation for Sickle Cell Disease Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| University of Louisville Hospital Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Mount SInai Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Univ. of California, San Francisco Health Care Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Withdrawn |
| St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Baskent University School of Medicine Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe Üniversitesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Not yet recruiting |
| Medical Park Mersin Hospital Coordinator of this site? Confirm its status | Mezitli-Mersin | Turkey (Türkiye) | Recruiting |
| Özel Acibadem Adana Hastanesi Coordinator of this site? Confirm its status | Seyhan | Turkey (Türkiye) | Recruiting |
| Özel Acibadem Adana Hastanesi Coordinator of this site? Confirm its status | Seyhan/Adana | Turkey (Türkiye) | Recruiting |
| Mersin Universitesi Coordinator of this site? Confirm its status | Yenişehir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.