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

Status:

APPROVED_FOR_MARKETING

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

Lead Sponsor:

Jeffrey Rudolph

Collaborating Sponsors:

University of Pittsburgh

Conditions:

Total Parenteral Nutrition-induced Cholestasis

Eligibility:

All Genders

2-10 years

Brief Summary

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 parente...

Detailed Description

In the United States, patients dependent upon parenteral nutrition (PN) receive parenteral fat emulsions composed of soybean oils. Lipids are necessary in PN dependent patients due to their high calor...

Eligibility Criteria

Inclusion

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.

Exclusion

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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01412359

Last Update

April 24 2019

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