This study is in progress, not accepting new patients

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

a study on Sickle Cell Anemia Vaso-Occlusive Crisis Anemia Acute Kidney Injury

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Keywords

Sickle Cell Disease Vaso-occlusive Crisis, Sickle cell disease, Acute kidney injury, Pharmacokinetics, Acute chest syndrome, Vaso-occlusive crisis, Hemopexin, Sickle Cell Anemia, Vaso-Occlusive Crises, Counterfeit Drugs, CSL889

Eligibility

You can join if…

Open to people ages 12 years and up

•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.

You CAN'T join if...

  • VOC pain onset 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 (>) 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 < 6 g/dL, serum ferritin >= 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.

Locations

  • University of California Irvine
    Orange 5379513 California 5332921 92868 United States
  • University of Cincinnati
    Cincinnati 4508722 Ohio 5165418 45267 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT06699849
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 260 study participants
Last Updated