Tests CSL889 for painful crises in people with sickle cell disease
Tests CSL889 given by vein during painful sickle cell crises in teens and adults.
Plain-language title generated from the registry record
Registry title: Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Key facts
- Where
- Amsterdam, Rotterdam, and Utrecht, NetherlandsSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and teenagers with sickle cell disease who come to the study site with a new painful vaso-occlusive crisis that needs strong pain medicine (opioids) given by injection or drip.
- Age
- 18 years or older; teenagers aged 12 to under 18 can join where approved and once the sponsor has opened enrollment for them.
- Sex
- All sexes can join.
- Disease stage
- Sickle cell disease of any genotype, with a new acute vaso-occlusive crisis that needs treatment with parenteral opioids.
- Earlier treatment
- People cannot join if they take an approved sickle cell medicine that has not been on a stable, well-tolerated regimen, or if they currently take methadone or buprenorphine.
- Biomarker or test result
- Serum hemoglobin must not be below 6 g/dL, and serum ferritin must not be 2000 ng/mL or higher.
Main reasons for not taking part
- Crisis pain began more than 72 hours before the first parenteral opioid
- More than 5 crises needing hospital admission in the past 6 months
- Signs or symptoms of acute chest syndrome, or new symptoms suggesting a stroke or transient ischemic attack
- Any stage of acute kidney injury
- Discharged from hospital for a vaso-occlusive event within the 14 days before the current presentation
Read by machine on 9 November 2026.
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsNo longer taking part
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsNo longer taking part
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CSL Behring
- Trial code
- NCT06699849EU 2024-513440-29-00
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; VOC pain onset greater than (>) 72 hours before administration of first parenteral opioid.