Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

Total Parenteral Nutrition-induced Cholestasis Clinical Trial

Official title:
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

Status Completed

Clinical Trial Summary

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholestasis
Total Parenteral Nutrition-induced Cholestasis

Clinical Trial Details

NCT number	NCT02534077
Study type	Interventional
Source	Mednax Center for Research, Education, Quality and Safety
Contact
Status	Completed
Phase	Phase 3
Start date	August 2015
Completion date	April 2019

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Withdrawn	`NCT01323907` - Compassionate Use of Omegaven IV Fat Emulsion	N/A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
Approved for marketing	`NCT02780193` - Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
Approved for marketing	`NCT02929303` - Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
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