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Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

Primary Purpose

Cholestasis

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Omegaven
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cholestasis focused on measuring short bowel syndrome, intestinal failure, total parenteral nutrition associated cholestasis

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC San Diego Medical Center
  • Rady Children's Hospital of San Diego

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 20, 2014
Last Updated
January 7, 2021
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02148146
Brief Title
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
Official Title
Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
short bowel syndrome, intestinal failure, total parenteral nutrition associated cholestasis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Omegaven
Intervention Description
Fish oil emulsion given 1g/kg/day as infusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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®) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Lazar, MPH
Organizational Affiliation
UC San Diego Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Rady Children's Hospital of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

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