Omegaven Expanded Access Protocol
- Conditions
- Parenteral Nutrition Associated Liver Disease
- Registration Number
- NCT02121769
- Lead Sponsor
- St. Luke's Health System, Boise, Idaho
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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 ā„ 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Luke's Pediatric Gastroenterology
šŗšøBoise, Idaho, United States