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Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Primary Purpose

Cholestasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fish oil lipid emulsion
Sponsored by
Kapiolani Medical Center For Women & Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring short bowel syndrome, parenteral nutrition associated liver disease, pediatric

Eligibility Criteria

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

Inclusion Criteria:

  • direct bilirubin > 2 mg/dl x2 consecutive
  • parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
  • patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

  • other primary cause of liver disease not parenteral nutrition-associated
  • weight <3 kg
  • infant or child enrolled in other clinical trial involving an investigational agent

Sites / Locations

  • Kapiolani Medical Center for Women and Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omegaven

Arm Description

Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs

Outcomes

Primary Outcome Measures

improving cholestasis
decline in serum direct bilirubin levels below 2 cm on 2 serial measures

Secondary Outcome Measures

improving liver function tests
includes ALT, AST, GGT, and triglycerides

Full Information

First Posted
June 17, 2010
Last Updated
February 12, 2019
Sponsor
Kapiolani Medical Center For Women & Children
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1. Study Identification

Unique Protocol Identification Number
NCT01194063
Brief Title
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Official Title
Use of Omegaven for Parenteral Nutrition Associated Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2010 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kapiolani Medical Center For Women & Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Detailed Description
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
short bowel syndrome, parenteral nutrition associated liver disease, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omegaven
Arm Type
Experimental
Arm Description
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Intervention Type
Drug
Intervention Name(s)
Omega-3 fish oil lipid emulsion
Other Intervention Name(s)
Omegaven
Intervention Description
daily intravenous administration of Omegaven fish oil emulsion
Primary Outcome Measure Information:
Title
improving cholestasis
Description
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
Time Frame
One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
Secondary Outcome Measure Information:
Title
improving liver function tests
Description
includes ALT, AST, GGT, and triglycerides
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: direct bilirubin > 2 mg/dl x2 consecutive parenteral nutrition dependent, expected to continue for at least another 30 days from the first day patient must have utilized standard therapies to prevent the progression of liver disease Exclusion Criteria: other primary cause of liver disease not parenteral nutrition-associated weight <3 kg infant or child enrolled in other clinical trial involving an investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn M Iwamoto, MD
Organizational Affiliation
Kapiolani Medical Center For Women & Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19687773
Citation
Lee SI, Valim C, Johnston P, Le HD, Meisel J, Arsenault DA, Gura KM, Puder M. Impact of fish oil-based lipid emulsion on serum triglyceride, bilirubin, and albumin levels in children with parenteral nutrition-associated liver disease. Pediatr Res. 2009 Dec;66(6):698-703. doi: 10.1203/PDR.0b013e3181bbdf2b.
Results Reference
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PubMed Identifier
20038849
Citation
de Meijer VE, Le HD, Meisel JA, Gura KM, Puder M. Parenteral fish oil as monotherapy prevents essential fatty acid deficiency in parenteral nutrition-dependent patients. J Pediatr Gastroenterol Nutr. 2010 Feb;50(2):212-8. doi: 10.1097/MPG.0b013e3181bbf51e.
Results Reference
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Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

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