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Omegaven Expanded Access Protocol

NCT02121769 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-04-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Tyler Burpee, MD · Pediatric Gastroenterology

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121769 on ClinicalTrials.gov