ClinicaliQ Trial Snapshot
- Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT06699849.
- What is being tested: CSL889 (human hemopexin) administered intravenously in a phase 2 randomized controlled trial to evaluate safety, efficacy, and pharmacokinetics in managing vaso-occlusive crises in sickle cell disease patients.
- Patient eligibility overview: Adults and adolescents with sickle cell disease who are experiencing acute vaso-occlusive crises and meet defined clinical criteria for study participation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * At the time of informed consent: * 18 years of age (adults); or * 12 to less than () 72 hours before administration of first parenteral opioid. * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.