Omegaven Expanded Access Protocol

Overview

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

  • Study Type: Expanded Access

Interventions

  • 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

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 17 Years

Investigator Details

  • 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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