Omegaven® as Parenteral Nutrition

The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) 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.

Study Overview

• Status: Unknown
• Conditions: Cholestasis
• Intervention / Treatment: Drug: Omegaven

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deveine Toney; Phone Number: (217) 326-4504; Email: deveine.toney@carle.com
• Study Contact Backup: Name: Mary Baker; Phone Number: (217)326-0058; Email: clinicaltrials@carle.com

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • Carle Foundation Hospital
      • Contact: Phone Number: 217-326-0058; Email: clinicaltrials@carle.com
      • Principal Investigator: William Stratton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Greater than 14 days old.
• Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4.
• Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.
• Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).
• Signed patient informed consent.
• The patient is expected to have a reasonable possibility of survival.
• No other known etiology of cholestasis other than PNALD at time of Omegaven® initiation.

Exclusion Criteria:

• Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to Omegaven® initiation.
• Known fish or egg allergy

• Any of the contraindications to use of Omegaven®:

  1. Active new infection at the time of initiation of Omegaven®
  2. Hemodynamic instability
  3. Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)
  4. Active coagulopathy or bleeding
  5. Thrombocytopenia
  6. Unstable hyperglycemia
  7. Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
  8. History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
  9. Unstable diabetes mellitus
  10. Collapse and shock
  11. Stroke/ Embolism
  12. Cardiac infarction within the last 3 months
  13. Undefined coma status
• Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• The parent or guardian of child is unwilling to provide consent or assent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Omegaven	Drug: Omegaven; Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)	Primary efficacy analysis will include time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN).	Until weaned from PN

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth (weight three times per week, length once weekly, and head circumference)	At a minimum, monitoring of growth parameters while on Omegaven® will include weight three times per week, length once weekly, and head circumference once weekly.	Until weaned from PN
Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)	We will monitor infants who are not receiving any enteral feeding at all for more than 4 weeks for any evidence of essential fatty acid (EFA) deficiency.	Until weaned from PN

Collaborators and Investigators

• Sponsor: Carle Foundation Hospital
• Investigators: Principal Investigator: William Stratton, MD, Carle Foundation Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Estimate): January 8, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: liver injury; liver disease; parenteral nutrition; Omegaven
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis
• Other Study ID Numbers: 13055