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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-01

Study Completion Date

2017-10-06

Brief Summary

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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.

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Detailed Description

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The primary objective of this study is to evaluate the need for and time to small bowel transplantation or liver transplantation. This will be calculated as both the age at time of primary transplant as well as the length of time from initial evaluation to transplant.Secondary objectives are to determine if there are improvements in clinical measures associated with established parenteral nutrition- associated liver disease (PNALD). These will be determined by measurement of total and direct bilirubin levels, platelet count, serum albumin, and changes in both length and weight growth curves.

Conditions

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Parenteral Nutrition Associated Liver Disease PNALD Cholestasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omegaven™

This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the parenteral nutrition (PN) lipid at 1g/kg/day, will be compared to historical controls at University of Nebraska Medical Center (UNMC) where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.

Group Type EXPERIMENTAL

Omegaven™

Intervention Type DRUG

10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Interventions

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Omegaven™

10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Intervention Type DRUG

Other Intervention Names

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Omega-3 fat emulsion

Eligibility Criteria

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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™

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No