Omegaven Expanded Access Protocol

April 8, 2019 updated by: Tyler Burpee, MD, St. Luke's Health System, Boise, Idaho

Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Pediatric Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Health System, Boise, Idaho

Investigators

  • Principal Investigator: Tyler Burpee, MD, Pediatric Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omegaven Expanded Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parenteral Nutrition Associated Liver Disease

Clinical Trials on Omegaven

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe