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NCT01954017 · ClinicalTrials.gov registry record · Phase 1
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
A Phase 1 study, sponsored by Leadiant Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT01954017: Completed Phase 1 study, sponsored by Leadiant Biosciences.
NCT01954017 is a Phase 1 study that has completed, run by Leadiant Biosciences. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954017, a Phase 1 study, has completed, sponsored by Leadiant Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study Summary
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
Primary Outcome
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Interventions
- OTHER Control
- BIOLOGICAL STP206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2014-01-30 |
| Est. Completion | 2018-10-22 |
| Phase | Phase 1 |
What the finished NCT01954017 record still lists
NCT01954017 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01954017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954017 about?
NCT01954017 is a clinical study titled "STP206 for the Prevention of Necrotizing Enterocolitis (NEC)". This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
What is the current status of trial NCT01954017?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2014-01-30. Estimated completion is 2018-10-22.
What interventions are being tested in trial NCT01954017?
The interventions under investigation include: Control (OTHER), STP206 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01954017?
This trial is sponsored by Leadiant Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01954017's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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