Omegaven Expanded Access Protocol

NO_LONGER_AVAILABLE

Conditions studied: Parenteral Nutrition Associated Liver Disease

In brief

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.

Key facts

Study ID

NCT02121769

Run by

St. Luke's Health System, Boise, Idaho

Last updated by the study team

2019-04-10

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
• Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
• Failed standard/conventional therapies to prevent progression of PNALD.
• Age newborn to 17 years of age
• Signed informed consent.

You may not qualify if…

• Allergy to eggs and/or shellfish
• Female who is pregnant or lactating
• Severe hemorrhagic disorder
• Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
• 18 years of age or older
• Parent/legally authorized representative is unwilling to consent.

Where it is running

• St. Luke's Pediatric Gastroenterology — Boise, Idaho, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.