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NCT04285827 · ClinicalTrials.gov registry record · Phase 1

Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease

A Phase 1 study of Sickle Cell Disease, sponsored by CSL Behring.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
15
Study locations

NCT04285827 is a Phase 1 study of Sickle Cell Disease that has completed, run by CSL Behring. The registered enrollment target is 28 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower). The trial reports 15 study locations across 9 states.

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The verdict

NCT04285827, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by CSL Behring.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
15
Study locations

Study Summary

This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of CSL889 following single intravenous (IV) doses in subjects with sickle cell disease (SCD). The study involves sequential dose escalation of cohorts with between-group assessments of key safety and PK variables.

Conditions Studied

Sickle Cell Disease

Interventions

  • BIOLOGICAL CSL889

Study Locations (15)

Other

  • Amsterdam UMC Academic Medical Center - Amsterdam
  • Erasmus University Medical Center - Rotterdam
  • Liverpool University Hospital - Liverpool
  • Guys and St. Thomas - London
  • University College London Hospital - London
  • Manchester University Hospitals NHS Foundation Trust / Manchester Royal Infirmary - Manchester
  • Early Phase Unit - Manchester

Illinois

  • University of Illinois Hospital and Health Science Systems - Chicago

Maryland

  • The Johns Hopkins Hospital - Baltimore

Minnesota

  • University of Minnesota - Minneapolis

New York

  • Jacobi Medical Center - The Bronx

North Carolina

  • Brody School of Medicine at East Carolina University - Greenville

Ohio

  • Ohio State University - Columbus

Pennsylvania

  • UPMC Hillman Cancer Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2021-05-20
Est. Completion 2023-07-24
Phase Phase 1

Sponsor

CSL Behring

71 total trials

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What the Registry Record Tells You About NCT04285827

The ClinicalTrials.gov registry entry for NCT04285827 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which CSL889 is the first listed.

NCT04285827 reports 15 study locations spanning 9 distinct geographic areas - top geographies include Other, Illinois, Maryland.

Frequently Asked Questions

What is clinical trial NCT04285827 about?

NCT04285827 is a clinical study titled "Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease". This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of CSL889 following single intravenous (IV) doses in subjects with sickle cell ...

What is the current status of trial NCT04285827?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-05-20. Estimated completion is 2023-07-24.

What conditions does trial NCT04285827 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT04285827?

The interventions under investigation include: CSL889 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04285827?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04285827 being conducted?

This trial has 15 study locations across Illinois, Maryland, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.