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Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

NCT03072667 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2018-12-06

No results posted yet for this study

Summary

This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.

Conditions

Interventions

DRUG

Omegaven

Omegaven™ will be initiated at 0.5 gm fat/kg of body weight per day (5cc/kg per day of Omegaven™) for 2 days. On day 3, the rate of Omegaven™ will be increased to 1g/kg (10cc/kg) per day and will remain at this level thereafter unless otherwise indicated.

Sponsors & Collaborators

  • St. Louis University

    collaborator OTHER

  • Catherine Cibulskis, MD

    lead OTHER

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03072667 on ClinicalTrials.gov