Evaluation of Omegaven™ Parenteral Nutrition in Patients With TPN-Induced Cholestasis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 15, 2009

Last Updated Date

May 4, 2009

Start Date ^†

April 2009

Current Primary Outcome Measures ^†

Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00826020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To determine if established PN associated liver disease can be reversed or its progression halted by using a fish oil parenteral emulsion as measured by normalization of serum levels of hepatic enzymes and bilirubin. [ Time Frame: weekly x 4, then bi-weekly x4, then monthly ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Evaluation of Omegaven™ Parenteral Nutrition in Patients With TPN-Induced Cholestasis

Official Title ^†

Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis

Brief Summary

The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Parenteral Nutrition Associated Liver Disease PNALD
Cholestasis

Intervention ^†

Drug: Omegaven™

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Enrolling by invitation

Estimated Enrollment ^†

100

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
Signed patient informed consent

Exclusion Criteria:

Parent or guardian or child unwilling to provide consent or assent
Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
Allergies or clinical conditions precluding safe use of Omegaven™

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00826020

Responsible Party

David Mercer, MD, PhD, University of Nebraska Medical Center

Secondary IDs ^††

Study Sponsor ^†

University of Nebraska

Collaborators ^††

Investigators ^†

Principal Investigator:

David F Mercer, MD, PhD

University of Nebraska

Information Provided By

University of Nebraska

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.