Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Phase 3CompletedNCT01194063

Kapiolani Medical Center For Women & Children36 enrolled

Overview

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cholestasis

Interventions

Omega-3 fish oil lipid emulsionDRUG

daily intravenous administration of Omegaven fish oil emulsion

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * direct bilirubin \> 2 mg/dl x2 consecutive * parenteral nutrition dependent, expected to continue for at least another 30 days from the first day * patient must have utilized standard therapies to prevent the progression of liver disease Exclusion Criteria: * other primary cause of liver disease not parenteral nutrition-associated * weight \<3 kg * infant or child enrolled in other clinical trial involving an investigational agent

Locations (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

improving cholestasis

decline in serum direct bilirubin levels below 2 cm on 2 serial measures

Time frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment

Secondary Outcomes

improving liver function tests

includes ALT, AST, GGT, and triglycerides

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.