Compassionate Use of Omegaven IV Fat Emulsion

NCT02477345 | Unknown

• 1 other identifier: SIUH12-025
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cholestasis; Liver Disease

Keywords

Cholestasis; Parenteral Nutrition; Liver disease

Interventions

Omegaven IV DRUG

Omegaven will be initiated at a dose of 0.5 gram/Kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/Kg/day. Omegaven will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven will continue until weaned from PN. Monotherapy with Omegaven can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/Kg/day, advancing to 1 gm/kg/day.

Also known as: Fat Emulsion

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Cholestasis; Liver Diseases; Hyperphagia

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Blau, MD

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: June 22, 2015
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

US (1)