Back to resultsUse of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Primary Purpose
Parenteral Nutrition-related Hepatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
About this trial
This is an interventional treatment trial for Parenteral Nutrition-related Hepatitis
Eligibility Criteria
Inclusion Criteria:
- The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
- Patient will be <18 years of age.
- Direct bilirubin > 2.0mg/dl
- The patient must have failed standard therapies to prevent progression his/her liver disease.
Exclusion Criteria:
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
- Patients who are allergic to eggs/shellfish
- Patients who have severe hemorrhagic disorders.
Sites / Locations
- Children's Mercy Hospitals and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overall Study
Arm Description
Use of Omegaven for patients with parenteral nutrition associated liver disease.
Outcomes
Primary Outcome Measures
Disease Progression as Measured by Serum Levels of Hepatic Enzymes
To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.
Secondary Outcome Measures
Full Information
NCT ID
NCT04697888
First Posted
December 15, 2020
Last Updated
June 1, 2021
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT04697888
Brief Title
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Official Title
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
5. Study Description
Brief Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
Detailed Description
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenteral Nutrition-related Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overall Study
Arm Type
Experimental
Arm Description
Use of Omegaven for patients with parenteral nutrition associated liver disease.
Intervention Type
Drug
Intervention Name(s)
Omegaven
Other Intervention Name(s)
IV Fish Oil Based Lipid Emulsion
Intervention Description
Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.
Primary Outcome Measure Information:
Title
Disease Progression as Measured by Serum Levels of Hepatic Enzymes
Description
To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
Patient will be <18 years of age.
Direct bilirubin > 2.0mg/dl
The patient must have failed standard therapies to prevent progression his/her liver disease.
Exclusion Criteria:
Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
Patients who are allergic to eggs/shellfish
Patients who have severe hemorrhagic disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel D Lim, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
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