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NCT02579265 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
A Phase 3 study, sponsored by Fresenius Kabi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 204
- Enrollment target
NCT02579265: Clinical Trial Phase 3 study, sponsored by Fresenius Kabi.
NCT02579265 is a Phase 3 study that was terminated before completion, run by Fresenius Kabi. The registered enrollment target is 204 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579265, a Phase 3 study, was terminated before completion, sponsored by Fresenius Kabi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 204 participants
- Enrollment target
Study Summary
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
Primary Outcome
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
Interventions
- DRUG Smoflipid 20% (investigational lipid for parenteral nutrition)
- DRUG Intralipid® 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 3 |
Why NCT02579265 stopped before completion
NCT02579265 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Smoflipid 20% (investigational lipid for parenteral nutrition) is the first listed.
NCT02579265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02579265 about?
NCT02579265 is a clinical study titled "Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants". To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.
What is the current status of trial NCT02579265?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 204 participants. The study started on 2015-12. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT02579265?
The interventions under investigation include: Smoflipid 20% (investigational lipid for parenteral nutrition) (DRUG), Intralipid® 20% (DRUG).
Who is sponsoring clinical trial NCT02579265?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02579265's enrollment target sits among peer trials
204 1352nd of 2000 higher than 649 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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