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
- Barcelona, Esplugues de Llobregat, Madrid, and Sevilla, SpainSee the 4 sites
- Phase
- Phase 2
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainNo 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?
Trial 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.