Clinical trials: Parenteral Nutrition Associated Liver Disease (PNALD)
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Cholestasis
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions.
- Trial name
- NCT02357576
- Testing
- Intralipid 20% I.V. Fat Emulsion
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Michigan
Parenteral Nutrition Associated Cholestasis
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Trial name
- NCT01601652
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Arthur J De Lorimier
Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome
Cholestasis Reversal: Efficacy of IV Fish Oil
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
- Conditions
- Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
- Trial name
- Reversal (NCT00910104)
- Testing
- Omegaven®
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Mark Puder
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either…
- Trial name
- NCT01323907
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Sivan Kinberg
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Liver Diseases
Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Liver Disease
The objective of the study is to show that substitution of the usual lipid emulsion (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1…
- Trial name
- MEGANORM (NCT01284049)
- Testing
- Intralipid 20%®, OMEGAVEN 10%®
- Where
- France
- Volunteers
- 31 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
Minimization of IntraLipid Versus Omegaven
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard…
- Trial name
- MILOve (NCT01247012)
- Testing
- Omegaven, Lipid minimization
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Children's & Women's Health Centre of British Columbia
Total Parenteral Nutrition-induced Cholestasis
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
- Trial name
- NCT02929303
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by…
- Trial name
- NCT00826020
- Testing
- Omegaven™
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Nebraska
Parenteral Nutrition Associated Liver Disease
Omegaven Expanded Access Protocol
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole…
- Trial name
- NCT02121769
- Testing
- Omegaven
- Where
- United States
- Sponsor
- St. Luke's Health System, Boise, Idaho
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD