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Recruiting Phase 4 Interventional

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

ClinicalTrials.gov ID: NCT06049680

Public ClinicalTrials.gov record NCT06049680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and/or Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06049680
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Fresenius Kabi
Industry
Enrollment
100 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Month to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 27, 2024
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026
Last update posted
Jul 16, 2026

2024 – 2026

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Emory University Hospital Atlanta Georgia 30322 Recruiting
The University of Chicago Chicago Illinois 60638 Not yet recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06049680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06049680 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →