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Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Primary Purpose

Total Parenteral Nutrition-induced Cholestasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omegaven®
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Parenteral Nutrition-induced Cholestasis focused on measuring PNALD, Cholestasis, Omegaven®, Short Bowel Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Children 0-18 years of age
  • Patients will be PN-dependent and expected to continue PN for at least 30 days
  • Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
  • Direct bilirubin > 2.0 mg/dl
  • Signed patient informed consent
  • Signed patient assent where applicable.

Exclusion Criteria:

  • Pregnancy
  • Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
  • Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
  • The patient is allergic to eggs/shellfish
  • The patient has a severe hemorrhagic disorder
  • The patient is enrolled 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.

Sites / Locations

  • Levine Children's Hospital at Carolinas HealthCare System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Single Omegaven® Intervention Arm

Outcomes

Primary Outcome Measures

Number of Participants With Normalization of Direct Bilirubin
Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months. This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease.

Secondary Outcome Measures

Number of Participants With Normal Essential Fatty Acid (EFA) Profiles.
EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is > 0.2). Collected monthly from month 1-9.
Number of Participants With Triglyceride Levels > 400 mg/dL
Number of participants with triglyceride levels > 400 mg/dL
Number of Participants With Unexpected Bleeding or Coagulopathies

Full Information

First Posted
April 29, 2013
Last Updated
November 9, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01845116
Brief Title
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Official Title
Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children. The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.
Detailed Description
Rationale for Omegaven® Treatment Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally. References Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Parenteral Nutrition-induced Cholestasis
Keywords
PNALD, Cholestasis, Omegaven®, Short Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Single Omegaven® Intervention Arm
Intervention Type
Drug
Intervention Name(s)
Omegaven®
Other Intervention Name(s)
IV Fish Oil Based Lipid Emulsion
Intervention Description
10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Primary Outcome Measure Information:
Title
Number of Participants With Normalization of Direct Bilirubin
Description
Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months. This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease.
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Number of Participants With Normal Essential Fatty Acid (EFA) Profiles.
Description
EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is > 0.2). Collected monthly from month 1-9.
Time Frame
Months 1 through 9
Title
Number of Participants With Triglyceride Levels > 400 mg/dL
Description
Number of participants with triglyceride levels > 400 mg/dL
Time Frame
baseline data and then weekly and monthly evaluations, for an average of 9 months
Title
Number of Participants With Unexpected Bleeding or Coagulopathies
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 0-18 years of age Patients will be PN-dependent and expected to continue PN for at least 30 days Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment Direct bilirubin > 2.0 mg/dl Signed patient informed consent Signed patient assent where applicable. Exclusion Criteria: Pregnancy Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency) Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites The patient is allergic to eggs/shellfish The patient has a severe hemorrhagic disorder The patient is enrolled 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A. Caicedo, MD
Organizational Affiliation
Levine Children's Hospital at Carolinas HealthCare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levine Children's Hospital at Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Upon study completion
Citations:
PubMed Identifier
19661785
Citation
Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
Results Reference
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PubMed Identifier
18310188
Citation
Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.
Results Reference
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PubMed Identifier
16818533
Citation
Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.
Results Reference
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Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

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