A Phase 2 / Phase 3, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Adaptive Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents with Sickle Cell Disease during Vaso-Occlusive Crisis
Eligibility
You can join if...
Inclusion Criteria:
At the time of informed consent: greater than or equal to 18 years of age (adults); or greater than or equal to 12 to less than (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 or equal to (greater than or equal to) 72 hours before administration of first parenteral opioid (Part A; may be adjusted for Part B based on prespecified analysis).
Must not have a history of greater than (greater than) 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 less than 6 g/dL, serum ferritin greater than or equal to 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.