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ClinicalTrials.gov public records Last synced Oct 2, 2026, 7:53 PM EDT

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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Cholestasis of Parenteral Nutrition Clear all
Recruiting No phase listed Observational

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

NCT06274788
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
Interventions
Omegaven® (fish oil triglycerides) Injectable Emulsion
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
1 Day to 17 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
10
States / cities
Fountain Valley, California • Los Angeles, California • Chicago, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2026 · Synced Oct 2, 2026, 7:53 PM EDT
Approved For Marketing No phase listed Expanded access

Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

NCT02328768
View directory record Official record
Conditions
Total Parenteral Nutrition-Induced Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
University of Nebraska
Other
Eligibility
Up to 18 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Jan 9, 2024 · Synced Oct 2, 2026, 7:53 PM EDT
Withdrawn Not applicable Interventional

Compassionate Use of Omegaven IV Fat Emulsion

NCT01323907
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven IV lipid emulsion
Drug
Lead sponsor
Sivan Kinberg
Other
Eligibility
2 Months to 18 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 6, 2020 · Synced Oct 2, 2026, 7:53 PM EDT
Recruiting Phase 4 Interventional

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

NCT06049680
View directory record Official record
Conditions
Malnutrition, Child, Malnutrition, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis
Interventions
SMOFlipid® (lipid injectable emulsion)
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
1 Month to 17 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
5
States / cities
Atlanta, Georgia • Chicago, Illinois • Indianapolis, Indiana + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2026 · Synced Oct 2, 2026, 7:53 PM EDT
Terminated Phase 4 Interventional Results available

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

NCT02476994
View directory record Official record
Conditions
Essential Fatty Acid Deficiency (EFAD)
Interventions
Clinolipid, Intralipid
Drug
Lead sponsor
Baxter Healthcare Corporation
Industry
Eligibility
Up to 17 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
4
States / cities
Park Ridge, Illinois • Indianapolis, Indiana • Columbus, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2021 · Synced Oct 2, 2026, 7:53 PM EDT
Terminated Not applicable Interventional

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

NCT01062815
View directory record Official record
Conditions
Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia, Necrotizing Enterocolitis
Interventions
Parenteral Nutrition
Dietary Supplement
Lead sponsor
University of Miami
Other
Eligibility
Up to 7 Days
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 23, 2015 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 2 Interventional Results available

Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01845116
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven®
Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
4 Weeks to 18 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2020
U.S. locations
1
States / cities
Charlotte, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 23, 2022 · Synced Oct 2, 2026, 7:53 PM EDT
Approved For Marketing No phase listed Expanded access

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

NCT01412359
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven®
Drug
Lead sponsor
Jeffrey Rudolph
Other
Eligibility
2 Months to 10 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 24, 2019 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 3 Interventional Results available

Omegaven as Alternative Parenteral Fat Nutrition

NCT03662282
View directory record Official record
Conditions
Cholestasis, Cholestasis of Parenteral Nutrition
Interventions
Omegaven
Drug
Lead sponsor
University of South Florida
Other
Eligibility
14 Days and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Jul 22, 2020 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Not applicable Interventional Results available

Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

NCT01050660
View directory record Official record
Conditions
Parenteral Nutrition-Associated Liver Disease
Interventions
Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
Other
Lead sponsor
Yale University
Other
Eligibility
12 Hours to 48 Hours
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 28, 2014 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Not applicable Interventional

Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?

NCT01891279
View directory record Official record
Conditions
Short Bowel Syndrome
Interventions
elemental formula Elecare®, partially hydrolyzed formula
Other
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
Up to 1 Year
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 7, 2021 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 1 Interventional

Cholestasis Prevention: Efficacy of IV Fish Oil

NCT00512629
View directory record Official record
Conditions
Cholestasis, Parenteral Nutrition
Interventions
Omegaven, Intralipid
Drug
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Up to 3 Months
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 3, 2020 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Not applicable Interventional Results available

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

NCT00738101
View directory record Official record
Conditions
Cholestasis, Cholestasis of Parenteral Nutrition
Interventions
Omegaven
Drug
Lead sponsor
Baylor College of Medicine
Other
Eligibility
14 Days to 5 Years
Enrollment
293 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2020
U.S. locations
2
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 28, 2021 · Synced Oct 2, 2026, 7:53 PM EDT
Approved For Marketing No phase listed Expanded access

Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193
View directory record Official record
Conditions
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Rush University Medical Center
Other
Eligibility
Up to 18 Years
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 8, 2019 · Synced Oct 2, 2026, 7:53 PM EDT
Completed No phase listed Observational

Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

NCT05011370
View directory record Official record
Conditions
Intestinal Failure-associated Liver Disease
Interventions
Not listed
Lead sponsor
Protara Therapeutics
Industry
Eligibility
12 Years to 80 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
10
States / cities
Los Angeles, California • Kissimmee, Florida • Chicago, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 3 Interventional Results available

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

NCT02357576
View directory record Official record
Conditions
Cholestasis
Interventions
Intralipid 20% I.V. Fat Emulsion
Drug
Lead sponsor
University of Michigan
Other
Eligibility
Up to 1 Year
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
5
States / cities
Aurora, Colorado • Gainesville, Florida • Ann Arbor, Michigan + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 17, 2020 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 3 Interventional

Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

NCT01194063
View directory record Official record
Conditions
Cholestasis
Interventions
Omega-3 fish oil lipid emulsion
Drug
Lead sponsor
Kapiolani Medical Center For Women & Children
Other
Eligibility
Up to 18 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2019
U.S. locations
1
States / cities
Honolulu, Hawaii
Source: ClinicalTrials.gov public record
Updated Apr 3, 2026 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 3 Interventional Results available

Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

NCT01555957
View directory record Official record
Conditions
Parenteral Nutrition Associated Cholestasis
Interventions
intravenous lipid
Drug
Lead sponsor
University of Rochester
Other
Eligibility
Up to 72 Hours
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Dec 3, 2020 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Compassionate Use of Omegaven in Children

NCT02370251
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
Interventions
Omegaven
Drug
Lead sponsor
University of Oklahoma
Other
Eligibility
Up to 18 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Nov 25, 2019 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Phase 4 Interventional Results available

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)

NCT04555044
View directory record Official record
Conditions
Essential Fatty Acid Deficiency (EFAD)
Interventions
Clinolipid, Intralipid
Drug
Lead sponsor
Baxter Healthcare Corporation
Industry
Eligibility
0 Years to 17 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
9
States / cities
Mobile, Alabama • New Haven, Connecticut • Orlando, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 27, 2023 · Synced Oct 2, 2026, 7:53 PM EDT
Terminated Phase 2 Interventional Results available

Compassionate Use of Omegaven IV Fat Emulsion

NCT00816348
View directory record Official record
Conditions
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Cindy Haller
Other
Eligibility
2 Weeks to 5 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2014
U.S. locations
2
States / cities
Manhasset, New York • New Hyde Park, New York
Source: ClinicalTrials.gov public record
Updated Mar 10, 2017 · Synced Oct 2, 2026, 7:53 PM EDT
No Longer Available No phase listed Expanded access

Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

NCT02148146
View directory record Official record
Conditions
Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
Up to 18 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
2
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Jan 12, 2021 · Synced Oct 2, 2026, 7:53 PM EDT
Completed Not applicable Interventional Results available

Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

NCT01173159
View directory record Official record
Conditions
Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
1 Month to 18 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2018
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jun 17, 2020 · Synced Oct 2, 2026, 7:53 PM EDT