Omegaven Expanded Access Protocol

Parenteral Nutrition Associated Liver Disease Clinical Trial

Official title:

Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02121769
• Other study ID #: Omegaven Expanded Access
• Status: No longer available

Study information

• Verified date: April 2019
• Source: St. Luke’s Health System, Boise, Idaho
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,)

• 18 years of age or older

• Parent/legally authorized representative is unwilling to consent.

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition Associated Liver Disease

Intervention

Drug:
• Omegaven
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.

Locations

Country	Name	City	State
United States	St. Luke's Pediatric Gastroenterology	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke’s Health System, Boise, Idaho

Country where clinical trial is conducted

United States,