Back to resultsCompassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Primary Purpose
Parenteral Nutrition Associated Cholestasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omegaven
Sponsored by
About this trial
This is an interventional treatment trial for Parenteral Nutrition Associated Cholestasis focused on measuring cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
Eligibility Criteria
Inclusion Criteria:
Cholestasis defined as either
- serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
- serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Exclusion Criteria:
- Age > 1y at time that omegaven is started
- Not expected to survive at least 30 days
- Fish allergy in a first degree relative
- Hemodynamic instability
- Coagulopathy
- Not likely to require PN for > 30d
- Not expected to survive > 30d
Sites / Locations
- University of California Davis Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omeagven
Arm Description
Outcomes
Primary Outcome Measures
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Secondary Outcome Measures
Liver Transaminases
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601652
Brief Title
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Official Title
Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arthur J De Lorimier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in 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
Parenteral Nutrition Associated Cholestasis
Keywords
cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omeagven
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Omegaven
Intervention Description
1 g/kg/d iv infusion over 24h
Primary Outcome Measure Information:
Title
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Time Frame
approximately for 4 months
Secondary Outcome Measure Information:
Title
Liver Transaminases
Time Frame
approximately for 4 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cholestasis defined as either
serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Exclusion Criteria:
Age > 1y at time that omegaven is started
Not expected to survive at least 30 days
Fish allergy in a first degree relative
Hemodynamic instability
Coagulopathy
Not likely to require PN for > 30d
Not expected to survive > 30d
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian J Griffin, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
We'll reach out to this number within 24 hrs