Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Total Parenteral Nutrition-induced Cholestasis

Treatments: Drug: Omegaven®

Study type: Interventional

Funder types: Other

Identifiers

NCT01845116

Omegaven 04-10-18B

Details and patient eligibility

About

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.

The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

Full description

Rationale for Omegaven® Treatment

Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

References

1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24.
2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.

Enrollment: 11 patients

Sex: All

Ages: 4 weeks to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children 0-18 years of age
• Patients will be PN-dependent and expected to continue PN for at least 30 days
• Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
• Direct bilirubin > 2.0 mg/dl
• Signed patient informed consent
• Signed patient assent where applicable.

Exclusion criteria

• Pregnancy
• Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
• Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
• The patient is allergic to eggs/shellfish
• The patient has a severe hemorrhagic disorder
• The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• The parent or guardian or child unwilling to provide consent or assent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Single Arm

Other group

Description:

Single Omegaven® Intervention Arm

Treatment:

Drug: Omegaven®