Omegaven Expanded Access Protocol

NCT02121769 | Unknown

• 1 other identifier: Omegaven Expanded Access
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Conditions

Parenteral Nutrition Associated Liver Disease

Keywords

cholestasis; short bowel syndrome

Interventions

Omegaven DRUG

10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
• Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
• Failed standard/conventional therapies to prevent progression of PNALD.
• Age newborn to 17 years of age
• Signed informed consent.

You may not qualify if:

• Allergy to eggs and/or shellfish
• Female who is pregnant or lactating
• Severe hemorrhagic disorder
• Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
• years of age or older
• Parent/legally authorized representative is unwilling to consent.

Sponsors & Collaborators

• St. Luke's Health System, Boise, Idaho: lead

Study Sites (1)

St. Luke's Pediatric Gastroenterology

Boise, Idaho, 83712, United States

Location

MeSH Terms

Conditions

Cholestasis; Short Bowel Syndrome

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tyler Burpee, MD

  Pediatric Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 24, 2014
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)