Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

Total Parenteral Nutrition-induced Cholestasis Clinical Trial

Official title:
Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease

Status Approved for marketing

Clinical Trial Summary

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.

This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

Clinical Trial Description

The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally. ;

Study Design

Related Conditions & MeSH terms

Cholestasis
Total Parenteral Nutrition-induced Cholestasis

Clinical Trial Details

NCT number	NCT02929303
Study type	Expanded Access
Source	Advocate Health Care
Contact
Status	Approved for marketing
Phase

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02370251` - Compassionate Use of Omegaven in Children	Phase 2/Phase 3
Completed	`NCT01845116` - Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury	Phase 2
Withdrawn	`NCT01323907` - Compassionate Use of Omegaven IV Fat Emulsion	N/A
Recruiting	`NCT01565278` - Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition	Phase 3
Terminated	`NCT00816348` - Compassionate Use of Omegaven IV Fat Emulsion	Phase 2
Completed	`NCT02534077` - Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants	Phase 3
Approved for marketing	`NCT02780193` - Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
Approved for marketing	`NCT01412359` - Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury
Approved for marketing	`NCT02328768` - Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children