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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 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.

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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.

Conditions Studied

Malnutrition Malnutrition, Child Essential Fatty Acid Deficiency (EFAD) Parenteral Nutrition Associated Cholestasis

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-10-28
Est. Completion 2026-09
Phase Phase 4

Sponsor

Fresenius Kabi

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06049680

The ClinicalTrials.gov registry entry for NCT06049680 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 383-participant average among 17 other Malnutrition trials with a reported enrollment target (74% lower). The listed sponsor is Fresenius Kabi, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.