Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

March 30, 2026 updated by: Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children

Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • direct bilirubin > 2 mg/dl x2 consecutive
  • parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
  • patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

  • other primary cause of liver disease not parenteral nutrition-associated
  • weight <3 kg
  • infant or child enrolled in other clinical trial involving an investigational agent

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omegaven
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Drug: Omega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion
Other Names:
  • Omegaven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improving cholestasis
Time Frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improving liver function tests
Time Frame: 1 year
includes ALT, AST, GGT, and triglycerides
1 year

Collaborators and Investigators

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

Sponsor

Kapiolani Medical Center For Women & Children

Investigators

  • Principal Investigator: Lynn M Iwamoto, MD, Kapiolani Medical Center For Women & Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 20, 2010

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimated)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Subscribe