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Omegaven® as Parenteral Nutrition

Primary Purpose

Cholestasis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
Carle Foundation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring Omegaven, parenteral nutrition, liver disease, liver injury

Eligibility Criteria

14 Days - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carle Foundation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Omegaven

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 6, 2015
Last Updated
January 7, 2015
Sponsor
Carle Foundation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02334293
Brief Title
Omegaven® as Parenteral Nutrition
Official Title
Omegaven® as Parenteral Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carle Foundation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
Omegaven, parenteral nutrition, liver disease, liver injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omegaven
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Omegaven
Intervention Description
Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Until weaned from PN
Secondary Outcome Measure Information:
Title
Growth (weight three times per week, length once weekly, and head circumference)
Description
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.
Time Frame
Until weaned from PN
Title
Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)
Description
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.
Time Frame
Until weaned from PN

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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®: Active new infection at the time of initiation of Omegaven® Hemodynamic instability Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs) Active coagulopathy or bleeding Thrombocytopenia Unstable hyperglycemia Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.) Unstable diabetes mellitus Collapse and shock Stroke/ Embolism Cardiac infarction within the last 3 months 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deveine Toney
Phone
(217) 326-4504
Email
deveine.toney@carle.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Baker
Phone
(217)326-0058
Email
clinicaltrials@carle.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Stratton, MD
Organizational Affiliation
Carle Foundation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
217-326-0058
Email
clinicaltrials@carle.com
First Name & Middle Initial & Last Name & Degree
William Stratton, MD

12. IPD Sharing Statement

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