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Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

NCT01412359 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-04-24

No results posted yet for this study

Summary

The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated cholestasis. It is a compassionate use protocol for patients who already have significant cholestasis related to parenteral nutrition.

Conditions

  • Total Parenteral Nutrition-induced Cholestasis

Interventions

DRUG

Omegaven®

Omegaven® 10% fat emulsion 1g/kg/day to infuse via IV over a period of 12 -24 hours every day until patient no longer requires intravenous lipid emulsion, is determined ineffective, or the patient stops participating in the study for any reason.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Jeffrey Rudolph

    lead OTHER

Principal Investigators

  • Jeffrey A Rudolph, MD · University of Pittsburgh

Eligibility

Min Age
2 Months
Max Age
10 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 NCT01412359 on ClinicalTrials.gov