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Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089426
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
Russell Merritt, Children's Hospital Los Angeles

Brief Summary:
This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

Condition or disease Intervention/treatment Phase
Liver Injury Drug: Omegaven™ Other: Historical Controls Not Applicable

Detailed Description:

In the United States, patients dependent upon parenteral nutrition (PN) receive parenteral fat emulsions composed of soybean oils. Lipids are necessary in PN dependent patients due to their high caloric value and essential fatty acid content. They have been implicated in predisposing patients to PN associated liver disease. Phytosterols such as those contained in soybean oils are thought to have a deleterious effect on biliary secretion.

Children requiring prolonged PN are at risk for developing PN associated liver disease. We hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. We further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as Omegaven™ would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum. Animal studies have shown that IV fat emulsions (IFE) such as fish oil that are high in eicosapentaenic and docashexaaenoic acid reduce impairment of bile flow which is seen in cholestasis caused by conventional fat emulsions. Intravenous omega three fatty acids may be well tolerated and might reduce the inflammatory effect in the liver of prolonged PN exposure and could potentially reverse any hepatic dysfunction due to PN/IFE use. By administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions we may reverse or prevent the progression of PN associated cholestasis and thus allow the patient to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research Study of an Intravenous Fat Emulsion Comprised of Fish Oils (Omegaven) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Study Start Date : September 2008
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Historical controls
A subset of patients previously seen, who have had at least 2 consecutive direct bilirubin levels > 2 mg/dL, who depended on parenteral nutrition for at least 90 days after surgical therapy for congenital or acquired intestinal diseases
Other: Historical Controls
Standard of Care

Experimental: Omegaven™ Drug: Omegaven™
1 g/kg/d of Omegaven until discontinuation of PN
Other Name: Highly refined fish oil for intravenous administration (10% Omegaven™)

Primary Outcome Measures :
  1. Rate of reduction of direct bilirubin [ Time Frame: normalization of direct bilirubin: an expected average of approximately 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients will be parenteral nutrition dependent and are expected to require PN for at least another 30 days
  • Patients must have parenteral nutrition associated liver disease (PNALD) as defined by having at least 2 consecutive direct bilirubins >2 mg/dl.

Exclusion Criteria:

  • Pregnancy
  • Other causes of liver disease
  • Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  • Direct bilirubin < 2 mg/dl
  • Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
  • Active coagulopathy characterized by on-going bleeding or acute need for clotting factor replacement such as FFP or cryoprecipitate to maintain homeostasis
  • Impaired lipid metabolism as defined by serum Tg level >400 at time of initiation of Omegaven
  • Unstable diabetes mellitus
  • Recent stroke/embolism, not including catheter related thrombosis, which is a common complication of central venous catheter.
  • Collapse and shock
  • Undefined coma status
  • Untreated infection at time of initiation of Omegaven
  • Hemodynamic instability
  • > 21 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01089426

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United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-6016
Sponsors and Collaborators
Children's Hospital Los Angeles
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Principal Investigator: Russell Merritt, M.D., PhD Children's Hospital Los Angeles


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Responsible Party: Russell Merritt, Medical Director of Nutrition Support and Intestinal Rehabilitation, Children's Hospital Los Angeles Identifier: NCT01089426     History of Changes
Other Study ID Numbers: CCI-08-00127
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Keywords provided by Russell Merritt, Children's Hospital Los Angeles:
Pediatric patients with Parenteral Nutrition (PN) induced Liver Injury

Additional relevant MeSH terms:
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Wounds and Injuries