Clinical Trial

Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 19 -> 26 locations 2026-08-15
notable Primary completion pushed: 2027-08-07 -> 2027-10-22 2026-04-17
minor Completion pushed: 2027-08-07 -> 2027-10-22 2026-04-17
Trial Details
NCT Number NCT06699849
Lead Sponsor CSL Behring
Conditions Sickle Cell Disease Vaso-occlusive Crisis
Enrollment 70 participants
Start Date 2025-08-07
Primary Completion 2027-10-22 (estimated)
Study Completion 2027-10-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-14