Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

Therapuetic Areas:Gastroenterology
Age Range:Any - 18
Start Date:March 2011
End Date:December 2018
Contact:Jae Kim, MD PhD

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Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis

This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat
emulsion in the treatment of liver disease associated with prolonged use of intravenous

Specific Aims of Study

1. To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)

2. To determine if established 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.

Inclusion Criteria:

1. Age < 18 years old

2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral
nutrition) and are expected to require PN for at least another 30 days, may be
inpatient or outpatient

3. Patients considered eligible for study participation must have parenteral nutrition
associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more.
Other causes of liver disease should be excluded. A liver biopsy is not necessary for

4. Direct bilirubin > 2.0 mg/dl

5. Signed patient informed consent

6. The patient must have utilized standard therapies to prevent the progression of
his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding,
reduction/removal of copper and manganese from PN, advancement of enteral feeding, or
the use of ursodiol (i.e., Actigall®)

Exclusion Criteria:

1. Pregnancy

2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia,
and alpha 1 anti-trypsin deficiency)

3. Enrollment in any other clinical trial involving an investigational agent (unless
approved by the designated physicians on the multidisciplinary team)

4. The parent or guardian or child unwilling to provide consent or assent

5. Patients known to be allergic to fish or egg protein and patients with the following
contraindications to Omegaven™ use:

- Impaired lipid metabolism

- Severe hemorrhagic disorders

- Unstable diabetes mellitus

- Collapse and shock

- Stroke/embolism

- Recent cardiac infarction

- Undefined coma status
We found this trial at
San Diego, California 92103
Principal Investigator: Jae H Kim, MD PhD
Phone: 619-543-3759
San Diego, CA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Phone: 858-966-4045
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
San Diego, CA
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