Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease

This study is currently recruiting participants.

Verified June 2011 by Kapiolani Medical Center For Women & Children

Sponsor:

Information provided by:

Kapiolani Medical Center For Women & Children

ClinicalTrials.gov Identifier:

NCT01194063

First received: June 17, 2010

Last updated: June 27, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2010

Last Updated Date

June 27, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

decline in serum direct bilirubin levels below 2 cm on 2 serial measures [ Time Frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

decline in serum direct bilirubin levels below 2 cm on 2 serial measures [ Time Frame: monthly ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01194063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

improving liver function tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]

includes ALT, AST, GGT, and triglycerides

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease

Official Title ^ICMJE

Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Brief Summary

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Parenteral Nutrition Associated Liver Disease

Intervention ^ICMJE

Drug: fish oil emulsion Omega 3 fatty acid

daily intravenous administration of Omegaven fish oil emulsion

Other Name: Omegaven

Study Arm (s)

Experimental: Omegaven

Intravenous administration of Omegaven fish oil emulsion

Intervention: Drug: fish oil emulsion Omega 3 fatty acid

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2015

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

direct bilirubin > 2 mg/dl x2 consecutive
parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

other primary cause of liver disease not parenteral nutrition-associated
weight <3 kg
infant or child enrolled in other clinical trial involving an investigational agent

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lynn M Iwamoto, MD	808-983-6000	lynni@kapiolani.org
Contact: Sidney Johnson, MD	808-983-6210	sidney.johnson@kapiolani.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01194063

Other Study ID Numbers ^ICMJE

107954

Has Data Monitoring Committee

Yes

Responsible Party

Lynn Iwamoto, Kapiolani Medical Center for Women and Children

Study Sponsor ^ICMJE

Kapiolani Medical Center For Women & Children

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lynn M Iwamoto, MD

Kapiolani Medical Center for Women and Children

Information Provided By

Kapiolani Medical Center For Women & Children

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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