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

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.

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