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

NCT01412359 | Unknown

• 1 other identifier: PRO08080394
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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 parenteral nutrition associated cholestasis. It is a compassionate use protocol for patients who already have significant cholestasis related to parenteral nutrition.

Conditions

Total Parenteral Nutrition-induced Cholestasis

Keywords

TPN Cholestasis

Interventions

Omegaven® DRUG

Omegaven® 10% fat emulsion 1g/kg/day to infuse via IV over a period of 12 -24 hours every day until patient no longer requires intravenous lipid emulsion, is determined ineffective, or the patient stops participating in the study for any reason.

Also known as: Intavenous fish oil emulsion

Eligibility Criteria

• Age: 2 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.
• 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.

Sponsors & Collaborators

• Jeffrey Rudolph: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Interventions

fish oil triglycerides

Study Officials

• Jeffrey A Rudolph, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 9, 2011
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

US (1)