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Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-04-08

No results posted yet for this study

Summary

The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.

Conditions

  • Cholestasis
  • Total Parenteral Nutrition-induced Cholestasis

Interventions

DRUG

Omegaven

Therapy with Omegaven® will be initiated and maintained at 1 g/kg/day. It will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If additional non-protein calories are needed, they will be provided as carbohydrates. No other parenteral form of fat emulsion will be used during Omegaven® therapy.The Omegaven® dose may be discontinued if the subject is receiving adequate enteral nutrition to meet metabolic and growth needs.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Aloka L Patel, MD · Rush University Medical Center

Eligibility

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 NCT02780193 on ClinicalTrials.gov