CSL889 for Sickle Cell Disease During Pain Crisis
Trial Summary
What is the purpose of this trial?
This study consists of two parts: phase 2 (Part A) and phase 3 (Part B). It is a multicenter study designed to evaluate the safety, effectiveness, 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 assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD, and to evaluate the safety and tolerability of CSL889 in study participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking methadone or buprenorphine.
Research Team
Study Director
Principal Investigator
CSL Behring
Eligibility Criteria
This trial is for adults and adolescents with Sickle Cell Disease (SCD) who are experiencing a pain crisis known as vaso-occlusive crisis (VOC). Participants must be at least 12 years old, diagnosed with any genotype of SCD, and require treatment with opioids for VOC.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CSL889 or placebo intravenously during vaso-occlusive crises
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CSL889
Find a Clinic Near You
Who Is Running the Clinical Trial?
CSL Behring
Lead Sponsor
Dr. Paul McKenzie
CSL Behring
Chief Executive Officer since 2023
PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania
Dr. Bill Mezzanotte
CSL Behring
Chief Medical Officer since 2021
MD from Duke University