Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
NCT ID: NCT04285827
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2021-05-20
2023-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CSL889 Cohort A1 (Dose 1)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort A2 (Dose 2)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort A3 (Dose 3)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort A4 (Dose 4)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort A5 (Dose 5)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort A6 (Dose 6)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort B1 (low dose)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
CSL889 Cohort B2 (high dose)
CSL889 administered as a single IV infusion
CSL889
Administered as an IV infusion
Interventions
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CSL889
Administered as an IV infusion
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 60 years, inclusive
* Stable SCD for at least 30 days before Day 1. Stable SCD is defined as the subject being at his or her medical baseline, with no evidence of worsening of disease over the last 30 days (including VOC, recent major surgery, hospitalization, serious infection, significant bleeding, cerebrovascular accident, seizures, or IV opioids)(Part A)
* Uncomplicated VOC requiring parenteral opioid treatment and admission to hospital for management. Uncomplicated VOC is defined as sickle cell pain without the following associated clinical features (Part B):
* Fever (\> 38.5 °C)
* Hypotension (\< 90/60 mmHg)
* Hypoxia (\< 90% oxygen saturation on room air, or requiring oxygen therapy to maintain oxygen saturation above 90%)
* New neurological signs and / or symptoms clinically suggestive of stroke or transient ischemic attack
* Signs and / or symptoms of Acute Chest Syndrome, accompanied by any new pulmonary infiltrate on chest radiography (chest X-ray to be performed if clinically indicated and according to local clinical guidelines)
* Subject is either not taking one of the study permitted SCD therapies (hydroxyurea, L-glutamine, L-glutaminecrizanlizumab, and/or voxelotor) or subject has been taking one or more of those for at least 30 days before Day 1 and is on a stable, well tolerated regimen that is planned to continue without change throughout the study
Exclusion Criteria
* History or evidence of inherited bleeding diathesis or significant coagulopathy at risk for bleeding
* Weight \>110 kg (242 lbs)
* Surgery within 30 days before Day 1 or any preplanned surgeries during the study (minor surgeries may be permitted under local anesthesia before screening, with permission of the medical monitor)
* Female subjects who are pregnant or breastfeeding
* Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of CSL889.
* Treatment with any other drug / biologic that is newly approved for SCD during the conduct of this study within 90 days before Day 1. Exceptions: crizanlizumab \[Adakveo®\] and voxelotor \[Oxbryta®\] \] are permitted (where prescribed).
* Treatment with another investigational product within 30 days or within 5 half-lives of the product (whichever is greater) before Day 1
* Vaccination within 30 days before Day 1, or planned vaccination during the study
* Body-mass index \< 16 kg/m2 or weight \< 50 kg (110 lbs)
* History of anaphylactic-type reactions, transfusion related reaction, asthma, or autoimmune disease
18 Years
60 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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University of Illinois Hospital and Health Science Systems
Chicago, Illinois, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Jacobi Medical Center
The Bronx, New York, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Amsterdam UMC Academic Medical Center
Amsterdam, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Liverpool University Hospital
Liverpool, , United Kingdom
Guys and St. Thomas
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Manchester University Hospitals NHS Foundation Trust / Manchester Royal Infirmary
Manchester, , United Kingdom
Early Phase Unit
Manchester, , United Kingdom
Countries
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Other Identifiers
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2019-001870-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL889_1001
Identifier Type: -
Identifier Source: org_study_id
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