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A pivotal phase III trial of IBP-9414 for prevention of necrotizing enterocolitis in premature infants

Trial Profile

A pivotal phase III trial of IBP-9414 for prevention of necrotizing enterocolitis in premature infants

Planning
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2018

At a glance

  • Drugs Lactobacillus reuteri (Primary)
  • Indications Acute enterocolitis
  • Focus Registrational; Therapeutic Use
  • Acronyms Connection
  • Sponsors Infant Bacterial Therapeutics
  • Most Recent Events

    • 21 Nov 2018 Planned initiation date changed from 1 Dec 2018 to 1 Jan 2019, according to an Infant Bacterial Therapeutics media release.
    • 21 Nov 2018 According to an Infant Bacterial Therapeutics media release, this study protocol is modified after meeting with the FDA. The process to modify the study protocol has already been started. Because of these changes this study is expected to start during the first half of 2019.
    • 14 Nov 2018 According to an Infant Bacterial Therapeutics media release, this study is expected to initiate during the fourth quarter of this year.
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