ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

Quick Facts

Study Start:2025-07-10
Study Completion:2027-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06699849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At the time of informed consent:
  2. * 18 years of age (adults); or
  3. * 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 \[IDMC\])
  4. * Diagnosed with SCD (any genotype).
  5. * Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.
  1. * VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid.
  2. * Must not have a history of \> 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.
  3. * 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.

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States
Golisano Children's Hospital
Fort Myers, Florida, 33908
United States
The Foundation for Sickle Cell Disease
Hollywood, Florida, 33023-6703
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
Jacobi Medical Center
The Bronx, New York, 10461
United States
Albert Einstein College of Medicine
The Bronx, New York, 10467
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
The Ohio State University
Columbus, Ohio, 43085
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10
Study Completion Date2027-08-07

Study Record Updates

Study Start Date2025-07-10
Study Completion Date2027-08-07

Terms related to this study

Keywords Provided by Researchers

  • Sickle cell disease
  • Acute kidney injury
  • Pharmacokinetics
  • Acute chest syndrome
  • Vaso-occlusive crisis
  • Hemopexin

Additional Relevant MeSH Terms

  • Sickle Cell Disease Vaso-occlusive Crisis