Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

NCT02328768 | Unknown

• 1 other identifier: 0018-15-FB
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.

Conditions

Total Parenteral Nutrition-Induced Cholestasis

Interventions

Omegaven DRUG

Also known as: Intravenous fish oil emulsion

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parenteral nutrition (PN) dependent (unable to meet nutritional needs solely by enteral nutrition) and expected to require PN for at least another 30 days.
• Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin ≥ 2mg/dL or by histology and/or currently on Omegaven through another protocol.
• Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
• Exhaustion of standard therapies to prevent the progression of the liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese form PN, advancement of enteral feeding, and the use of ursodiol.

You may not qualify if:

• Pregnancy
• Other causes of liver disease
• Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• The parent/guardian or subject is unwilling to provide consent and assent

Sponsors & Collaborators

• University of Nebraska: lead
• Children's Hospital and Medical Center, Omaha, Nebraska: collaborator

Study Sites (1)

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Interventions

fish oil triglycerides

Study Officials

• Brian A Jones, MD

  University of Nebraska Medical Center/Children's Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 31, 2014
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

US (1)