NO_LONGER_AVAILABLENot Applicable

Omegaven Expanded Access Protocol

United States

Plain-language 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.

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Trial details

NCT IDNCT02121769

SponsorSt. Luke's Health System, Boise, Idaho

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Parenteral Nutrition Associated Liver Disease trials