Summary

for people ages up to 18 years (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Jae H Kim

Description

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.

Official Title

Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis

Details

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.

Keywords

Cholestasis short bowel syndrome intestinal failure total parenteral nutrition associated cholestasis Omegaven

Eligibility

You can join if…

Open to people ages up to 18 years

  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®)

You CAN'T join if...

  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:
  6. Impaired lipid metabolism
  7. Severe hemorrhagic disorders
  8. Unstable diabetes mellitus
  9. Collapse and shock
  10. Stroke/embolism
  11. Recent cardiac infarction
  12. Undefined coma status

Locations

  • UC San Diego Medical Center accepting new patients
    San Diego California 92103-8774 United States
  • Rady Children's Hospital of San Diego accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02148146
Phase
Phase 1/2
Lead Scientist
Jae H Kim
Study Type
Interventional
Last Updated
May 2017