Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

January 8, 2019 updated by: Cook Children's Health Care System
This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This expanded access protocol provides a mechanism for critically ill infants with parenteral nutrition-associated liver disease (PNALD) to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

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
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center

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

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Greater than 4 weeks (28 days) old and less then 5 years of age
  • Diagnosis of PNALD as defined by serum direct bilirubin greater than 2 mg/dL on 2 consecutive occasions
  • Expected to require intravenous nutrition for at least an additional 28 days
  • Have been PN-dependent for at least four weeks prior to planned Omegaven initiation
  • PN-dependent and unable to meet nutritional requirements by enteral means
  • Have failed standard therapies to prevent progression of PNALD
  • Hospitalized at time of Omegaven initiation

Exclusion Criteria:

  • Have a congenitally lethal condition (e.g. Trisomy 13).
  • Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  • Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
  • Have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than Omegaven during the study period.
  • Severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease
  • Bleeding disorder
  • Biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.

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

Cook Children's Health Care System

Investigators

  • Principal Investigator: Bankole O Osuntokun, MD, MS, Cook Children's Medical Center

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 Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-059

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.

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