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NCT06049680 · ClinicalTrials.gov registry record · Phase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
A Phase 4 study of Malnutrition and Malnutrition, Child, sponsored by Fresenius Kabi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT06049680: Recruiting Phase 4 study of Malnutrition and Malnutrition, Child, sponsored by Fresenius Kabi.
NCT06049680 is a Phase 4 study of Malnutrition and Malnutrition, Child that is actively recruiting participants, run by Fresenius Kabi. The registered enrollment target is 100 participants, below the 383-participant average among 17 other Malnutrition trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06049680, a Phase 4 study of Malnutrition and Malnutrition, Child, is actively recruiting participants, sponsored by Fresenius Kabi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
Primary Outcome
defined as direct bilirubin level \> 2 mg/dL, confirmed by a second sample collected 7 days after the first sample
Conditions Studied
Interventions
- DRUG SMOFlipid® (lipid injectable emulsion)
Study Locations (5)
Georgia
- Emory University Hospital - Atlanta
Illinois
- The University of Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Ohio
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What NCT06049680 shows while recruiting
NCT06049680 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 383-participant average among 17 other Malnutrition trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Malnutrition appearing as the primary indexed condition, and to 1 intervention - of which SMOFlipid® (lipid injectable emulsion) is the first listed.
NCT06049680 lists 5 locations in 5 states (Georgia, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT06049680 about?
NCT06049680 is a clinical study titled "Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients". Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
What is the current status of trial NCT06049680?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-10-28. Estimated completion is 2026-09.
What conditions does trial NCT06049680 study?
This clinical trial studies the following conditions: Malnutrition, Malnutrition, Child, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis.
What interventions are being tested in trial NCT06049680?
The interventions under investigation include: SMOFlipid® (lipid injectable emulsion) (DRUG).
Who is sponsoring clinical trial NCT06049680?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06049680 being conducted?
This trial has 5 study locations across Georgia, Illinois, Indiana, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malnutrition
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06049680's enrollment target sits among peer trials
100 11th of 17 higher than 7 of 17 other Malnutrition trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malnutrition 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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