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NCT03857841 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A Phase 1 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03857841 is a Phase 1 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 3 participants.
The verdict
NCT03857841, a Phase 1 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
Interventions
- BIOLOGICAL UNEX-42
- BIOLOGICAL Phosphate-buffered saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03857841
The ClinicalTrials.gov registry entry for NCT03857841 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which UNEX-42 is the first listed.
NCT03857841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03857841 about?
NCT03857841 is a clinical study titled "A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD". A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
What is the current status of trial NCT03857841?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-10-09. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT03857841?
The interventions under investigation include: UNEX-42 (BIOLOGICAL), Phosphate-buffered saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT03857841?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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