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Pivotal Phase 3 clinical trial wo-cycle treatment on pediatric and adolescent patients with an early-onset type 1 diabetes (T1D) diagnosis to demonstrate preservation of beta cell function, improvement in glycemic control and decreased insulin use

Trial Profile

Pivotal Phase 3 clinical trial wo-cycle treatment on pediatric and adolescent patients with an early-onset type 1 diabetes (T1D) diagnosis to demonstrate preservation of beta cell function, improvement in glycemic control and decreased insulin use

Planning
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2018

At a glance

  • Drugs Teplizumab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms PROTECT
  • Sponsors MacroGenics
  • Most Recent Events

    • 13 Aug 2018 According to Provention Bio media release, trial is expected to be start in the second half of 2019.
    • 16 May 2018 According to Provention Bio media release, trial is expected to be start in late 2019
    • 16 May 2018 New trial record
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