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Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

Primary Purpose

Cholestasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring Parenteral Nutrition, Cholestasis

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females ages one month of age to 18 years of age
  • Patients with intestinal failure on TPN
  • Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
  • Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
  • Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
  • Signed informed consent for use of Omegaven® obtained

Exclusion Criteria:

  • Any of the contraindications to use of Omegaven®

    • Impaired lipid metabolism (triglycerides >1000 mg/dL) while on

      1g/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
    • Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
    • Females of child-bearing potential who are unwilling to use birth control during study participation
  • Parental decision to forego the use of Omegaven®
  • Known fish or egg allergy
  • Pregnancy
  • Causes of liver disease other than Parenteral Nutrition Associated Cholestasis

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omegaven

Arm Description

Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Outcomes

Primary Outcome Measures

Number of Participants With a Change in Conjugated/Direct Bilirubin
Change in conjugated/direct bilirubin level to below 1 mg/dl.

Secondary Outcome Measures

Number of Participants With a Change in Unconjugated/Total Bilirubin
Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Number of Participants With a Change in Aspartate Transaminase (AST)
Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Number of Participants With a Change in Liver Enzyme (ALT)
Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Number of Participants With a Change in Triglycerides
Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.

Full Information

First Posted
July 29, 2010
Last Updated
June 8, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01173159
Brief Title
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Official Title
Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Detailed Description
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
Parenteral Nutrition, Cholestasis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Omegaven
Arm Type
Experimental
Arm Description
Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
Intervention Type
Drug
Intervention Name(s)
Omegaven
Intervention Description
For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
Primary Outcome Measure Information:
Title
Number of Participants With a Change in Conjugated/Direct Bilirubin
Description
Change in conjugated/direct bilirubin level to below 1 mg/dl.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Secondary Outcome Measure Information:
Title
Number of Participants With a Change in Unconjugated/Total Bilirubin
Description
Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Title
Number of Participants With a Change in Aspartate Transaminase (AST)
Description
Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Title
Number of Participants With a Change in Liver Enzyme (ALT)
Description
Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Title
Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
Description
Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Title
Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
Description
Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)
Title
Number of Participants With a Change in Triglycerides
Description
Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
Time Frame
Completion of Therapy (time frame from 1-14 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ages one month of age to 18 years of age Patients with intestinal failure on TPN Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator. Signed informed consent for use of Omegaven® obtained Exclusion Criteria: Any of the contraindications to use of Omegaven® Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1g/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 Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential Females of child-bearing potential who are unwilling to use birth control during study participation Parental decision to forego the use of Omegaven® Known fish or egg allergy Pregnancy Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Kocoshis, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

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