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Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year

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Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 14 Dec 2022

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At a glance

  • Drugs Soya oil emulsion/medium-chain triglyceride/olive oil/fish oil (Primary) ; Soya oil emulsion
  • Indications Malnutrition
  • Focus Adverse reactions; Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Sponsors Fresenius Kabi

    • Most Recent Events

    • 30 Sep 2022 Status changed from recruiting to discontinued.
    • 04 Mar 2021 Planned End Date changed from 1 Nov 2020 to 1 Aug 2024.
    • 04 Mar 2021 Planned primary completion date changed from 1 Nov 2020 to 1 Aug 2024.

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