NCT02929303

Brief Summary

This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

First QC Date

September 13, 2016

Last Update Submit

September 29, 2025

Conditions

Total Parenteral Nutrition-induced Cholestasis

Interventions

Omegaven IV lipid emulsionDRUG

Therapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients aged 0 - 18 yrs
  • Patients must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
  • consecutive direct bilirubins \> 2.0 mg/dl. one week apart.
  • Signed patient informed consent.
  • The patient must have utilized standard therapies as clinically appropriate to prevent the progression of his/her liver disease. Such therapies could include surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i.e.,Actigall).

You may not qualify if:

  • Documented cause of chronic liver disease other than parenteral nutrition associated liver disease.
  • An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven.
  • Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis.
  • Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis.(e.g. (triglycerides \> 1000mg/dl while receiving intralipid 1g/kg/day or less)
  • Unstable diabetes mellitus or hyperglycemia (Blood glucose \>200 mg/dL) at the time of initiation of Omegaven
  • Currently being treated for stroke, embolism, collapse and shock, myocardial infarction.
  • Cholestasis due to any reason other than parenteral associated liver disease
  • Active new infection at time of initiation of Omegaven
  • Hemodynamic instability (e.g. receiving vasopressors) at time of initiation of Omegaven.
  • The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
  • Known pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Children's Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (2)

  • Sant'Anna AM, Altamimi E, Clause RF, Saab J, Mileski H, Cameron B, Fitzgerald P, Sant'Anna GM. Implementation of a multidisciplinary team approach and fish oil emulsion administration in the management of infants with short bowel syndrome and parenteral nutrition-associated liver disease. Can J Gastroenterol. 2012 May;26(5):277-80. doi: 10.1155/2012/571829.

    PMID: 22590701RESULT

  • Soden JS, Lovell MA, Brown K, Partrick DA, Sokol RJ. Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. J Pediatr. 2010 Feb;156(2):327-31. doi: 10.1016/j.jpeds.2009.08.033.

    PMID: 20105644RESULT

Study Officials

  • Hector Hernandez, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

October 11, 2016

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

US(1)