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Showing 1–24 of 32 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Parenteral Nutrition Associated Cholestasis Clear all
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 8, 2024 · Synced Jul 22, 2026, 2:07 AM 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 2, 2023 · Synced Jul 22, 2026, 2:07 AM 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 11, 2021 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 5, 2020 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM EDT
Approved For Marketing No phase listed Expanded access

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

NCT02534077
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven, Omegaven
Dietary Supplement · Drug
Lead sponsor
Pediatrix
Other
Eligibility
14 Days to 2 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jul 25, 2024 · Synced Jul 22, 2026, 2:07 AM 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 9, 2017 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM EDT
Terminated Phase 4 Interventional Results available

Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders

NCT01373918
View directory record Official record
Conditions
Cholestasis
Interventions
Intralipid
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
1 Minute to 5 Days
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
2
States / cities
Los Angeles, California • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 15, 2016 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM EDT
Completed Not applicable Interventional

Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

NCT00004414
View directory record Official record
Conditions
Cholestasis
Interventions
sincalide
Drug
Lead sponsor
University of Michigan
Other
Eligibility
Up to 30 Days
Enrollment
252 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2002
U.S. locations
6
States / cities
Baltimore, Maryland • Ann Arbor, Michigan • Rochester, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM EDT
No Longer Available No phase listed Expanded access

Omegaven Expanded Access Protocol

NCT02121769
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
St. Luke's Health System, Boise, Idaho
Other
Eligibility
Up to 17 Years
U.S. locations
1
States / cities
Boise, Idaho
Source: ClinicalTrials.gov public record
Updated Apr 9, 2019 · Synced Jul 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM 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 22, 2026, 2:07 AM EDT