CSL Behring
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 Criteria: * 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 Criteria: * VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid. * Must not have a history of \> 5 VOCs requ…
CSL889 is a solution for infusion to be administered by the IV route.
Volume and regimen matched to CSL889 will be administered.