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Taking peoplePhase 2

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.

Key facts

Who runs it
CSL Behring
Where
Barcelona, Esplugues de Llobregat, Madrid, and Sevilla, SpainSee the 4 sitesAlso in 9 other countries, 54 sites
Registry title
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Status
Recruiting
Phase
Phase 2
People taking part
70 people, planned
Started
10 Jul 2025
Expected to end
22 Oct 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • CSL889
  • Placebo
Record updated
8 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Spain

Also in 9 other countries, 54 sites

  • 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

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • CSL889 Regimen 1Treatment being tested

    Participants in this arm will receive CSL889 as per regimen 1.

    Treatment: CSL889

  • CSL889 Regimen 2Treatment being tested

    Participants in this arm will receive CSL889 as per regimen 2.

    Treatment: CSL889

  • PlaceboPlacebo, for comparison

    Participants in this arm will receive placebo matching to CSL889 regimen.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests CSL889 for painful crises in people with sickle cell diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 October 2026