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

APPROVED_FOR_MARKETING

Conditions studied: Total Parenteral Nutrition-induced Cholestasis

In brief

The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated cholestasis. It is a compassionate use protocol for patients who already have significant cholestasis related to parenteral nutrition.

Key facts

Study ID

NCT01412359

Run by

Jeffrey Rudolph

Last updated by the study team

2019-04-24

Who can join

Age: 0 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be 2 months -10 years of age.
• Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
• Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of >2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
• 2 consecutive direct bilirubin test results >2.0mg/dL
• The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall).
• Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of< 2, but who remain TPN dependent and require continued therapy with Omegaven.

You may not qualify if…

• Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency)
• Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• The parent, guardian, or child is unwilling to provide consent or assent
• Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
• Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
• Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
• Unstable diabetes mellitus
• Stroke/embolism
• Collapse and shock
• Undefined coma status
• Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture.

Where it is running

• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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