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Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage

NCT01861834 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-05-07

No results posted yet for this study

Summary

To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.

Conditions

  • Cholestasis of Parenteral Nutrition

Interventions

DRUG

Omegaven 10%

Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant. Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Eligibility

Min Age
2 Months
Max Age
18 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 NCT01861834 on ClinicalTrials.gov