NCT02148146

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

First QC Date

May 20, 2014

Last Update Submit

January 7, 2021

Conditions

Cholestasis

Keywords

short bowel syndromeintestinal failuretotal parenteral nutrition associated cholestasis

Interventions

OmegavenDRUG

Fish oil emulsion given 1g/kg/day as infusion

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age \< 18 years old
  • 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
  • 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
  • Direct bilirubin \> 2.0 mg/dl
  • Signed patient informed consent
  • 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 may not qualify if:

  • Pregnancy
  • Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
  • Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  • The parent or guardian or child unwilling to provide consent or assent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC San Diego Medical Center

San Diego, California, 92037, United States

Location

Rady Children's Hospital of San Diego

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

CholestasisShort Bowel SyndromeIntestinal Failure

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Lazar, MPH

    UC San Diego Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 28, 2014

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

US(2)