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.
Full Title of Study: “Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) – Omegaven IND 122375″
- Study Type: Expanded Access
- Drug: Omegaven
- 10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 17 Years
- Lead Sponsor
- St. Luke’s Health System, Boise, Idaho
- Provider of Information About this Clinical Study
- Principal Investigator: Tyler Burpee, MD, Principal Investigator – St. Luke’s Health System, Boise, Idaho
- Overall Official(s)
- Tyler Burpee, MD, Principal Investigator, Pediatric Gastroenterology
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