Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

January 25, 2021 updated by: Arthur J De Lorimier

Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omeagven
Drug: Omegaven
1 g/kg/d iv infusion over 24h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Time Frame: approximately for 4 months
approximately for 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver Transaminases
Time Frame: approximately for 4 months
approximately for 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthur J De Lorimier

Investigators

  • Principal Investigator: Ian J Griffin, MD, UC Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225576
  • UCD#225576-3 (Other Identifier: UC Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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