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Showing 1–24 of 29 matching trials from the live ClinicalTrials.gov search.
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
Conditions
Parenteral Nutrition-related Hepatitis
Interventions
Omegaven
Drug
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
Up to 17 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Kansas City, Missouri
Terminated Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

SMOFlipid to Lessen the Severity of Neonatal Cholestasis

NCT02721277
Conditions
Cholestasis, Jaundice, Obstructive
Interventions
SMOFlipid
Drug
Lead sponsor
University of Florida
Other
Eligibility
23 Weeks to 1 Year
Enrollment
2 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2017
U.S. locations
1
States / cities
Gainesville, Florida
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
Conditions
Cancer, Hepatic Injury
Interventions
Omegaven
Drug
Lead sponsor
Midwestern Regional Medical Center
Other
Eligibility
18 Years to 80 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Zion, Illinois
Conditions
Hematopoietic Stem Cell Transplantation
Interventions
Omegaven, Soybean oil lipid emulsion
Drug
Lead sponsor
Alexandra N. Carey
Other
Eligibility
2 Years to 18 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
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
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
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
Conditions
Kidney Diseases
Interventions
Canola oil, Arginine, Fish oil emulsion
Dietary Supplement
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
4 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Ends 2004
U.S. locations
4
States / cities
Washington D.C., District of Columbia • Baltimore, Maryland • Durham, North Carolina + 1 more
Conditions
Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction
Interventions
SMOFLipid, Intralipid
Dietary Supplement
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 75 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Rochester, Minnesota
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
Completed Phase 2Phase 3 Interventional Results available

Compassionate Use of Omegaven in Children

NCT02370251
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
Conditions
Home Parenteral Nutrition, Short Bowel Syndrome
Interventions
SMOFLipid, Standard therapy
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Retinopathy of Prematurity
Interventions
Omegaven, Standard lipids (primarily omega-6 fatty acids)
Drug · Dietary Supplement
Lead sponsor
University of California, San Diego
Other
Eligibility
Up to 7 Days
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
1
States / cities
La Jolla, California
Completed Phase 2Phase 3 Interventional Results available

Cholestasis Reversal: Efficacy of IV Fish Oil

NCT00910104
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
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
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
Conditions
Liver Disease
Interventions
Intravenous Lipid Emulsion Comprised of Fish Oil
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
14 Days to 24 Months
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
San Antonio, Texas
Conditions
Prematurity
Interventions
Intralipid, 20% Intravenous Emulsion, Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
0 Days to 8 Days
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Houston, Texas
Conditions
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Interventions
Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
0 Weeks and older
Enrollment
204 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
13
States / cities
Palo Alto, California • San Diego, California • New Haven, Connecticut + 8 more
Conditions
Malnutrition, Child
Interventions
Smoflipid, Intralipid, 20%
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
3 Months to 16 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Conditions
Human Milk, Neonate, Breast Milk
Interventions
Targeted Fortification, The Miris Human Milk Analyzer
Dietary Supplement · Device
Lead sponsor
MetroHealth Medical Center
Other
Eligibility
Up to 6 Months
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Cleveland, Ohio