260 Participants Needed

CSL889 for Sickle Cell Disease During Pain Crisis

Recruiting at 3 trial locations
TR
Overseen ByTrial Registration Coordinator
Prior Safety DataThis treatment has passed at least one previous human trial

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

SD

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

I have been diagnosed with sickle cell disease.
I am at least 18 years old, or between 12 and 17 where allowed.
I am at the hospital for a sudden pain crisis needing strong painkillers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CSL889 or placebo intravenously during vaso-occlusive crises

Up to 28 days
Multiple visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 28 days
End of study visit (EOS)

Treatment Details

Interventions

  • CSL889
Trial OverviewThe study tests CSL889, given intravenously to see if it can shorten the time it takes for VOC to resolve in patients. It's compared against a placebo in a two-part study that includes assessing its safety and how the body processes it.
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: CSL889Experimental Treatment1 Intervention
Participants in this arm will receive CSL889, as per regimen selected after Part A.
Group II: Part A: CSL889 Regimen A3Experimental Treatment1 Intervention
Participants in this arm will receive CSL889 as per regimen A3.
Group III: Part A: CSL889 Regimen A2Experimental Treatment1 Intervention
Participants in this arm will receive CSL889 as per regimen A2.
Group IV: Part A: CSL889 Regimen A1Experimental Treatment1 Intervention
Participants in this arm will receive CSL889 as per regimen A1.
Group V: Part B: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo matching the selected CSL889 regimen after Part A.
Group VI: Part A: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo matching to CSL889 regimen of Part A.

Find a Clinic Near You

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials
204
Recruited
1,207,000+
Dr. Paul McKenzie profile image

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 profile image

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University