Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

NCT04697888 | Completed Phase 2 Results

• 1 other identifier: 12010063
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

Conditions

Parenteral Nutrition-related Hepatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Study Arms (1)

Overall Study

EXPERIMENTAL

Use of Omegaven for patients with parenteral nutrition associated liver disease.

Drug: Omegaven

Interventions

Omegaven DRUG

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.

Also known as: IV Fish Oil Based Lipid Emulsion

Overall Study

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

fish oil triglycerides

Results Point of Contact

• Title: Joel Lim, MD - Principal Investigator
• Organization: Children's Mercy Hospital

jlim@cmh.edu

(816)234-3000

Study Officials

• Joel D Lim, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND.

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 6, 2021
• Study Start: April 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 11, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-06

Locations

US (1)