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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Cholestasis of Parenteral Nutrition Clear all
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 22, 2022 · Synced Jul 23, 2026, 12:39 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 6, 2021 · Synced Jul 23, 2026, 12:39 PM EDT
Completed Phase 4 Interventional Results available

Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

NCT00862446
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
Up to 24 Months
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2019
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 4, 2021 · Synced Jul 23, 2026, 12:39 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 22, 2015 · Synced Jul 23, 2026, 12:39 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 20, 2021 · Synced Jul 23, 2026, 12:39 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 27, 2021 · Synced Jul 23, 2026, 12:39 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 27, 2014 · Synced Jul 23, 2026, 12:39 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 16, 2026 · Synced Jul 23, 2026, 12:39 PM EDT
Completed Phase 3 Interventional Results available

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

NCT03387579
View directory record Official record
Conditions
Cholestasis of Parenteral Nutrition
Interventions
Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
Drug
Lead sponsor
Indiana University
Other
Eligibility
Not listed
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Jul 29, 2025 · Synced Jul 23, 2026, 12:39 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 16, 2020 · Synced Jul 23, 2026, 12:39 PM EDT
Not listed Phase 2 Interventional

Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

NCT01739517
View directory record Official record
Conditions
Short Bowel Syndrome, Cholestasis
Interventions
Omegaven Therapy
Drug
Lead sponsor
Amarnath, Rathna, M.D.
Individual
Eligibility
Up to 1 Year
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Columbia, South Carolina
Source: ClinicalTrials.gov public record
Updated Dec 2, 2012 · Synced Jul 23, 2026, 12:39 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 2, 2020 · Synced Jul 23, 2026, 12:39 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

NCT01601652
View directory record Official record
Conditions
Parenteral Nutrition Associated Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Arthur J De Lorimier
Other
Eligibility
Up to 1 Year
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Jan 26, 2021 · Synced Jul 23, 2026, 12:39 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Cholestasis Reversal: Efficacy of IV Fish Oil

NCT00910104
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
Interventions
Omegaven®
Drug
Lead sponsor
Mark Puder
Other
Eligibility
Up to 17 Years
Enrollment
91 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2019
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Jul 23, 2026, 12:39 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 2, 2026 · Synced Jul 23, 2026, 12:39 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 21, 2020 · Synced Jul 23, 2026, 12:39 PM EDT
Completed Phase 2 Interventional Results available

Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

NCT00826020
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Interventions
Omegaven™
Drug
Lead sponsor
University of Nebraska
Other
Eligibility
19 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2017
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Oct 4, 2023 · Synced Jul 23, 2026, 12:39 PM EDT
No Longer Available No phase listed Expanded access

Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

NCT02925520
View directory record Official record
Conditions
Parenteral Nutrition-Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
Cook Children's Health Care System
Other
Eligibility
4 Weeks to 5 Years
U.S. locations
1
States / cities
Fort Worth, Texas
Source: ClinicalTrials.gov public record
Updated Jan 9, 2019 · Synced Jul 23, 2026, 12:39 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 23, 2019 · Synced Jul 23, 2026, 12:39 PM EDT
Approved For Marketing No phase listed Expanded access

Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

NCT01297933
View directory record Official record
Conditions
Cholestasis, Short Bowel Syndrome
Interventions
Omegaven
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
Up to 21 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 11, 2019 · Synced Jul 23, 2026, 12:39 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 24, 2019 · Synced Jul 23, 2026, 12:39 PM EDT
Approved For Marketing No phase listed Expanded access

Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage

NCT01861834
View directory record Official record
Conditions
Cholestasis of Parenteral Nutrition
Interventions
Omegaven 10%
Drug
Lead sponsor
Georgetown University
Other
Eligibility
2 Months to 18 Years
U.S. locations
2
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated May 6, 2019 · Synced Jul 23, 2026, 12:39 PM EDT