Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

• Conditions: Cholestasis

• Registration Number: NCT02148146
• Lead Sponsor: University of California, San Diego

Brief Summary

This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

Detailed Description

Specific Aims of Study

1. To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)

2. To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age < 18 years old
2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days, may be inpatient or outpatient
3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
4. Direct bilirubin > 2.0 mg/dl
5. Signed patient informed consent
6. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)

Exclusion Criteria

1. Pregnancy

2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)

3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)

4. The parent or guardian or child unwilling to provide consent or assent

5. Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:

   • Impaired lipid metabolism
   • Severe hemorrhagic disorders
   • Unstable diabetes mellitus
   • Collapse and shock
   • Stroke/embolism
   • Recent cardiac infarction
   • Undefined coma status

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (2)

UC San Diego Medical Center; 🇺🇸 San Diego, California, United States

Rady Children's Hospital of San Diego; 🇺🇸 San Diego, California, United States