Compassionate Use of Omegaven IV Fat Emulsion

NCT00816348 | Terminated Phase 2 Results

• 1 other identifier: 08-204
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cholestasis; Total Parenteral Nutrition-induced Cholestasis

Keywords

Cholestasis; Parenteral Nutrition Associated Liver Disease

Outcome Measures

Primary Outcomes (1)

• Level of Bilirubin

  measurement of bilirubin level weekly. Available data reported.

  week 2, 3,4,and 8

Study Arms (1)

Omegaven

OTHER

All subjects will receive Omegaven

Drug: Omegaven

Interventions

Omegaven 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.

Omegaven

Eligibility Criteria

• Age: 2 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
• Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
• The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).

You may not qualify if:

• Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
• Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
• An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
• 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 or severe hyperlipidemia with or without pancreatitis
• Unstable diabetes mellitus or hyperglycemia
• Stroke, embolism, collapse and shock, recent MI
• Cholestasis due to any reason other than parenteral associated liver disease
• Active new infection at time of initiation of Omegaven®
• Hemodynamic instability
• The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).

Sponsors & Collaborators

• Cindy Haller: lead

Study Sites (2)

Cohen Children's Medical Cenetr of New York at North Shore

Manhasset, New York, 11030, United States

Location

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Cindy Haller MD
• Organization: NSLIJ Health System

challer@lij.edu

516-472-3650

Study Officials

• Cindy Haller, MD

  Cohen Children's Medical Center of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 10, 2017
• Results First Posted: February 9, 2016

Record last verified: 2017-01

Locations

US (2)