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

Description

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.

Conditions

Sickle Cell Disease Vaso-occlusive Crisis
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Related Conditions:

Sickle Cell Disease Vaso-occlusive Crisis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sickle Cell Disease Vaso-occlusive Crisis
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine, Orange, California, United States, 92868

Fort Myers

Golisano Children's Hospital, Fort Myers, Florida, United States, 33908

Hollywood

The Foundation for Sickle Cell Disease, Hollywood, Florida, United States, 33023-6703

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

New York

Mount Sinai Medical Center, New York, New York, United States, 10029

The Bronx

Jacobi Medical Center, The Bronx, New York, United States, 10461

The Bronx

Albert Einstein College of Medicine, The Bronx, New York, United States, 10467

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45267

Columbus

The Ohio State University, Columbus, Ohio, United States, 43085

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosed with SCD (any genotype).
  • * Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.
  • * 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

2028-04-04