MedTrace Logo

Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

NCT02925520 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-01-10

No results posted yet for this study

Summary

This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

Conditions

  • Parenteral Nutrition-Associated Liver Disease

Interventions

DRUG

Omegaven

Therapy with Omegaven will be provided at a dose of 1 gm/kg/day infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed. Home Use of Omegaven: The Omegaven dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the provider.

Sponsors & Collaborators

  • Cook Children's Health Care System

    lead OTHER

Principal Investigators

  • Bankole O Osuntokun, MD, MS · Cook Children's Medical Center

Eligibility

Min Age
4 Weeks
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

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 NCT02925520 on ClinicalTrials.gov