Use of Omegaven for Parenteral Nutrition Associated Liver Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- improving cholestasis
Study Overview
Brief Summary
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Detailed Description
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •direct bilirubin > 2 mg/dl x2 consecutive
- •parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
- •patient must have utilized standard therapies to prevent the progression of liver disease
Exclusion Criteria
- •other primary cause of liver disease not parenteral nutrition-associated
- •weight <3 kg
- •infant or child enrolled in other clinical trial involving an investigational agent
Arms & Interventions
Omegaven
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Intervention: Omega-3 fish oil lipid emulsion (Drug)
Outcomes
Primary Outcomes
improving cholestasis
Time Frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
Secondary Outcomes
- improving liver function tests(1 year)
Investigators
Lynn M. Iwamoto
MD, Associate Professor of Pediatrics
Kapiolani Medical Center For Women & Children