TPN-Related Cholestasis Treatment with Omegaven - Phase II

Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition-Associated Hepatic Injury

Protocol Description

This multi-center study provides an alternative nutritional source for critically ill patients suffering from severe liver disease associated with total parenteral nutrition (TPN). Parenteral nutrition (PN) is a nutritional solution given intravenously to patients unable to tolerate adequate oral feedings. Although PN solutions are necessary and life sustaining, their use can sometimes result in cholestasis, for which there is no effective treatment. Patients enrolled in the study will receive Omegaven®, an intravenous fat emulsion made from omega-3 fish oils, rather than the soybean oils used in standard fat emulsions. Other trials have shown that Omegaven is well tolerated, provides nutritional fat components, and might reduce the inflammatory effect in the liver that occurs with prolonged use of PN.

Study Level: Phase II

Eligibility Criteria

As a compassionate use protocol, this study enrolls only critically ill patients who are at least 2 months old, who have life-threatening PN-associated cholestasis, and who have failed all standard therapies to prevent the progression of their liver disease. All other causes of cholestasis must be ruled out and all subjects must be under the care of the Intestinal Care and Rehabilitation Center (ICARE) at Children’s Hospital of Pittsburgh of UPMC.
Boys: 2 months to 10 years
Girls: 2 months to 10 years

Requirements

The ICARE Center will provide therapy with Omegaven by continuous infusion through either a central or peripheral catheter in conjunction with PN until it is no longer required.
Visits: Requires hospitalization upon initiation
Duration: Determined by the study doctors based on individual patient response to therapy

Status: Enrollment by Invitation Only

Primary Investigator

Jeffery Rudolph, MD

Contact Information

For more information about this study or enrollment, please contact:
Catherine Scott, BS, CRC
412-692-7673