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Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

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ClinicalTrials.gov Identifier: NCT02929303
Expanded Access Status : Available
First Posted : October 11, 2016
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hector Hernandez, Advocate Health Care

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.


Condition or disease Intervention/treatment
Total Parenteral Nutrition-induced Cholestasis Drug: Omegaven IV lipid emulsion

Detailed Description:
The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

Study Type : Expanded Access
Official Title: Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Omegaven IV lipid emulsion
    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.

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Pediatric patients aged 0 - 18 yrs
  2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition). It will be assumed that patients will require parenteral nutrition for at least 30 days from the inclusion into the study.
  3. 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.
  4. 2 consecutive direct bilirubins > 2.0 mg/dl. one week apart.
  5. Signed patient informed consent.
  6. 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).

Exclusion Criteria:

  1. Documented cause of chronic liver disease other than parenteral nutrition associated liver disease.
  2. An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven.
  3. Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis.
  4. Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis.(e.g. (triglycerides > 1000mg/dl while receiving intralipid 1g/kg/day or less)
  5. Unstable diabetes mellitus or hyperglycemia (Blood glucose >200 mg/dL) at the time of initiation of Omegaven
  6. Currently being treated for stroke, embolism, collapse and shock, myocardial infarction.
  7. Cholestasis due to any reason other than parenteral associated liver disease
  8. Active new infection at time of initiation of Omegaven
  9. Hemodynamic instability (e.g. receiving vasopressors) at time of initiation of Omegaven.
  10. 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).
  11. Known pregnancy.

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 ClinicalTrials.gov identifier (NCT number): NCT02929303


Contacts
Contact: Hector Hernandez, MD (847) 723-7700 Hector.hernandez@advocatehealth.com
Contact: Paul Kasprzak, Rph, BCPS (708) 684-5749 paul.kasprzak@advocatehealth.com

Locations
United States, Illinois
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
Contact: Kelly Kopec, PharmD    847-723-8370    kelly.kopec@advocatehealth.com   
Contact: Paul Kasprzak, Rph, BCPS    (708) 684-5749    paul.kasprzak@advocatehealth.com   
Principal Investigator: Hector Hernandez, MD         
Sub-Investigator: Paul Kasprzak, Rph, BCPS         
Sub-Investigator: Kelly Kopec, PharmD         
Sponsors and Collaborators
Hector Hernandez