Clinical trials: Parenteral Nutrition Associated Cholestasis
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
Cholestasis, Short Bowel Syndrome
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).
- Trial name
- Omegaven (NCT01297933)
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
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
Short Bowel Syndrome, Cholestasis
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.
- Trial name
- NCT01739517
- Testing
- Omegaven Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Amarnath, Rathna, M.D.
Cholestasis
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II.
- Trial name
- NCT00004414
- Testing
- sincalide
- Where
- 6 sites in United States
- Volunteers
- 252 people
- Sponsor
- University of Michigan
Cholestasis
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
- Trial name
- NCT01194063
- Testing
- Omega-3 fish oil lipid emulsion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Kapiolani Medical Center For Women & Children
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
Cholestasis
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
- Trial name
- NCT02148146
- Testing
- Omegaven
- Where
- 2 sites in United States
- Sponsor
- University of California, San Diego
Parenteral Nutrition Associated Cholestasis
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
- Trial name
- NCT01555957
- Testing
- intravenous lipid
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Rochester
Cholestasis
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.
- Trial name
- FO (NCT00969332)
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of California, Los Angeles
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
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 of Parenteral Nutrition
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may…
- Trial name
- NCT01861834
- Testing
- Omegaven 10%
- Where
- 2 sites in United States
- Sponsor
- Georgetown University
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Short Bowel Syndrome
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS.
- Trial name
- NCT01974336
- Testing
- ursodeoxycholic acid
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jinling Hospital, China
Premature Birth
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene…
- Trial name
- TPNAC (NCT01062724)
- Testing
- Primene 10 % from Baxter
- Where
- Mexico
- Volunteers
- 94 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Liver Disease
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates.
- Trial name
- NCT02947594
- Volunteers
- 37 people
- Sponsor
- Università Politecnica delle Marche