Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Phase 3

Completed

• Conditions: Cholestasis
• Interventions: Drug: Omega-3 fish oil lipid emulsion

• Registration Number: NCT01194063
• Lead Sponsor: Kapiolani Medical Center For Women & Children

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 Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Study Start: 2010-10-20
• Primary Completion: 2018-11-30
• Study Completion: 2019-01-15
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omegaven	Omega-3 fish oil lipid emulsion	Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs

Primary Outcome Measures

Name	Time	Method
improving cholestasis	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 Outcome Measures

Name	Time	Method
improving liver function tests	1 year	includes ALT, AST, GGT, and triglycerides

Trial Locations

Locations (1)

Kapiolani Medical Center for Women and Children; 🇺🇸 Honolulu, Hawaii, United States