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Omegaven as Alternative Parenteral Fat Nutrition

Primary Purpose

Cholestasis, Cholestasis of Parenteral Nutrition

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
University of South Florida
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, Cholestasis

Eligibility Criteria

14 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Greater than 14 days old
  • Has parenteral nutrition 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
  • Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks
  • Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol
  • Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels
  • Signed patient informed consent
  • The patient is expected to have a reasonable possibility of survival
  • No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation

Exclusion Criteria:

  • Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, 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. Recent use of medications with associated risk of bleeding, including NSAIDs
    4. Active coagulopathy or bleeding
    5. Platelet counts persistently under 30,000 despite transfusions
    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

Sites / Locations

  • USF Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug - Omegaven®

Arm Description

Therapy with Omegaven® will be initiated at the goal dose of 0.5-1/kg/day. The default is over 24 hours, but shorter intervals may be considered if a program of total parenteral nutrition cycling is recommended. Omegaven® will be infused intravenously through either a central or peripheral catheter.

Outcomes

Primary Outcome Measures

Number of Participant With Decrease in Direct Bilirubin Level
Number of participant with decrease in direct bilirubin levels within 30 days of treatment

Secondary Outcome Measures

Number of Participant With Resolution of Direct Hyperbilirubinemia
Number of participant with Direct bilirubin level of <2mg/dL at discontinuation of treatment
Number of Participant With Preservation of Length
Monitoring of weekly length while the patient is receiving Omegaven® treatment
Number of Participant With Preservation of Head Circumference
Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment
Number of Participant With Preservation of Normal Weight Gain
Monitoring of daily weight gain while the patient is on Omegaven®

Full Information

First Posted
July 23, 2018
Last Updated
July 7, 2020
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03662282
Brief Title
Omegaven as Alternative Parenteral Fat Nutrition
Official Title
Omegaven as Alternative Parenteral Fat Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis
Detailed Description
An intermediate population, Investigational New Drug study, to provide an alternate intravenous fat nutrition, Omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis, Cholestasis of Parenteral Nutrition
Keywords
Omegaven, parenteral nutrition, Liver disease, Cholestasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - Omegaven®
Arm Type
Experimental
Arm Description
Therapy with Omegaven® will be initiated at the goal dose of 0.5-1/kg/day. The default is over 24 hours, but shorter intervals may be considered if a program of total parenteral nutrition cycling is recommended. Omegaven® will be infused intravenously through either a central or peripheral catheter.
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 parenteral nutrition associated liver injury
Primary Outcome Measure Information:
Title
Number of Participant With Decrease in Direct Bilirubin Level
Description
Number of participant with decrease in direct bilirubin levels within 30 days of treatment
Time Frame
First month of treatment
Secondary Outcome Measure Information:
Title
Number of Participant With Resolution of Direct Hyperbilirubinemia
Description
Number of participant with Direct bilirubin level of <2mg/dL at discontinuation of treatment
Time Frame
2 months
Title
Number of Participant With Preservation of Length
Description
Monitoring of weekly length while the patient is receiving Omegaven® treatment
Time Frame
Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Title
Number of Participant With Preservation of Head Circumference
Description
Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment
Time Frame
Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Title
Number of Participant With Preservation of Normal Weight Gain
Description
Monitoring of daily weight gain while the patient is on Omegaven®
Time Frame
Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Greater than 14 days old Has parenteral nutrition 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 Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels Signed patient informed consent The patient is expected to have a reasonable possibility of survival No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation Exclusion Criteria: Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, 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 Recent use of medications with associated risk of bleeding, including NSAIDs Active coagulopathy or bleeding Platelet counts persistently under 30,000 despite transfusions 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thao Ho, DO
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Omegaven as Alternative Parenteral Fat Nutrition

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