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Completed

NCT Number: NCT01845116

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

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.

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Key information

Conditions

Total Parenteral Nutrition-induced Cholestasis Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

4 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Levine Children's Hospital at Carolinas HealthCare System

Charlotte, North Carolina, 28232-2861, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omegaven®

Drug

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.

Other names: IV Fish Oil Based Lipid Emulsion

Primary outcomes

  1. Number of Participants With Normalization of Direct Bilirubin

    Time frame: Month 9

    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 outcomes

  1. Number of Participants With Normal Essential Fatty Acid (EFA) Profiles.

    Time frame: Months 1 through 9

    EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is > 0.2). Collected monthly from month 1-9.

  2. 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

    Number of participants with triglyceride levels > 400 mg/dL

  3. Number of Participants With Unexpected Bleeding or Coagulopathies

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
May 3, 2013
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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