A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2019-02-12

Brief Summary

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The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.

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Detailed Description

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Infants dependent on parenteral nutrition for greater than 1 year who develop parenteral nutrition associated cholestasis will universally face mortality unless they receive a timely liver and/or small bowel transplant. Although transplant survival has improved in recent years, survival is not guaranteed, and transplant care remains costly. Alternative nutritional and pharmacological strategies are imperative to improve the clinical outcomes of infants with intestinal failure and parenteral nutrition associated cholestasis. In both animal and human studies, intravenous fish oil, a lipid emulsion rich in omega-3 fatty acids and Vitamin E, and lacking phytosterols, has been shown to ameliorate parenteral nutrition associated cholestasis and improve morbidity and mortality. The purpose of this pilot study is to investigate if Omegaven, a commercially available intravenous fish oil, at 1 g/kg/d, will safely reverse liver disease in 80 subjects with parenteral nutrition associated cholestasis. Subjects can initially receive a maximum of 6 months (24 weeks) of intravenous fish oil. If the subject re-develops liver disease and still satisfies inclusion/exclusion criteria, the intervention can be restarted. Study subjects will be compared to a historical cohort of children with Short Bowel Syndrome and parenteral nutrition associated cholestasis who have been receiving standard intravenous soybean oil for \> 60 days. The fish oil cohort will be followed for a total of 5 years to determine if transplant-free mortality is reduced.

Conditions

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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

0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.

Group Type EXPERIMENTAL

Omegaven

Intervention Type DRUG

0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday

Interventions

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Omegaven

0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical evidence of parenteral nutrition associated cholestasis
* Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
* Expected parenteral nutrition course greater than 30 days
* Acquired or congenital gastrointestinal disease
* \> 2 weeks of age and \< 18 years of age
* \> 60% calories from parenteral nutrition
* Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

Exclusion Criteria

* Inborn errors of metabolism
* Extracorporeal Membrane Oxygenation
* Seafood, egg, or Omegaven allergy
* Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
* Hemorrhagic disorder
* Anticoagulant therapy
* Hemodynamically unstable or in shock
* Comatose state
* Stroke, pulmonary embolism, recent myocardial infarction
* Diabetes
* Fatal chromosomal disorder
* Enrollment in any other clinical trial involving an investigational agent
* Patient, parent, or legal guardians unable or unwilling to give consent
* Patient expected to be weaned from parenteral nutrition in 30 days
* unable to tolerate necessary monitoring
* Patient requiring aspirin or toradel or motrin
* Patient requiring dialysis

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No