Other Clinical Trial - Omegaven Expanded Access Protocol

Status No longer available

Clinical Trial Summary

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 IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Liver Diseases
Parenteral Nutrition Associated Liver Disease

Clinical Trial Details

NCT number	NCT02121769
Study type	Expanded Access
Source	St. Luke’s Health System, Boise, Idaho
Contact
Status	No longer available
Phase

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00910104` - Cholestasis Reversal: Efficacy of IV Fish Oil	Phase 2/Phase 3
Recruiting	`NCT01157780` - Parenteral Nutrition Associated Liver Disease: Early Markers and Therapy Wih Enteral Omega-3 Supplementation	N/A
Completed	`NCT00862446` - Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease	Phase 4
Completed	`NCT03442361` - Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Chemistry and Clinical Outcomes	N/A
Completed	`NCT05181085` - Study of NST-6179 in Healthy Subjects	Phase 1
Completed	`NCT02010034` - Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury	N/A
Completed	`NCT05347888` - How Well do we Feed the Critically Ill Patients
Withdrawn	`NCT04807478` - Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
Approved for marketing	`NCT03561194` - Omegaven Protocol:Intermediate Size Patient Population