Compassionate Use of Omegaven in Children

Status Completed

Clinical Trial Summary

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Clinical Trial Description

Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.

Up to 200 children will be eligible for enrollment.

Direct bilirubin levels and other labs will be monitored as well as growth parameters. ;

Study Design

Related Conditions & MeSH terms

Cholestasis
Cholestasis of Parenteral Nutrition
Gastroschisis
Infant, Premature, Diseases
Intestinal Atresia
Short Bowel Syndrome
Total Parenteral Nutrition-induced Cholestasis

Clinical Trial Details

NCT number	NCT02370251
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2015
Completion date	September 27, 2019

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05635747` - A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
Completed	`NCT01891279` - Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?	N/A
Completed	`NCT00930644` - Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)	Phase 3
Completed	`NCT01696656` - Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency	N/A
Completed	`NCT00910104` - Cholestasis Reversal: Efficacy of IV Fish Oil	Phase 2/Phase 3
Completed	`NCT04981262` - Improved Quality of Life in Children With Intestinal Failure	N/A
Completed	`NCT01930539` - Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp	N/A
Recruiting	`NCT05023382` - A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Recruiting	`NCT04733066` - Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Terminated	`NCT00742157` - Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)	Phase 4
Completed	`NCT04743960` - Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition	N/A
Completed	`NCT03690206` - Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)	Phase 3
Terminated	`NCT02266849` - Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study	Phase 3
Completed	`NCT01306838` - Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy	Early Phase 1
Completed	`NCT01380366` - rHGH and Intestinal Permeability in Intestinal Failure	Phase 4
Completed	`NCT00248573` - Mechanisms of Adaptation in Human Short Bowel Syndrome	Phase 1/Phase 2
Withdrawn	`NCT03371862` - Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)	Phase 2
Completed	`NCT04474743` - Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
Completed	`NCT00067860` - Diet/Growth Factor Mechanisms of Gut Adaptation	Phase 2
Terminated	`NCT04046328` - Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome	Phase 2