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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: Completed Phase 1 study of Sickle Cell Disease, sponsored by CSL Behring.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 1 |
What the finished NCT04285827 record still lists
NCT04285827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower).
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 lists 15 locations in 9 states (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.
Learn More About Clinical Trials
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Where NCT04285827's enrollment target sits among peer trials
28 148th of 213 higher than 64 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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