Compassionate Use of Omegaven IV Fat Emulsion

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health

Criteria

Inclusion Criteria:

• subjects will be infants and children from birth to 5 years of age

• diagnosis of parenteral nutrition associated liver disease (PNALD) (defined as two consecutive direct bilirubin levels of 2 mg/dl or more) in a parenteral nutrition-dependent infant or child.

• subject must have utilized standard therapies to prevent the progression of the cholestasis including reduction/removal of copper and manganese from daily PN, trial of enteral feedings if possible, and the use of ursodiol and/or phenobarbital.

Exclusion Criteria:

• patients are excluded if they have other documented causes of chronic liver disease (i.e.: Hepatitis C, cystic fibrosis, biliary atresia, alpha-1-anti-trypsin deficiency),

• or already have signs of proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.

Additional exclusion criteria:

• an active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis

• impaired lipid metabolism

• severe hyperlipidemia with or without pancreatitis

• unstable diabetes mellitus

• hyperglycemia

• stroke, embolism

• collapse and shock

• recent myocardial infarction (MI)

• cholestasis due to any reason other than parenteral nutrition associated cholestasis (PNAC)

• active new infection at time of initiation of Omegaven

• hemodynamic instability

• patient cannot be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)