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A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease

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Trial Profile

A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 16 Oct 2019

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At a glance

  • Drugs Etrolizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Roche

    • Most Recent Events

    • 11 Oct 2019 Planned End Date changed from 16 Mar 2024 to 20 Sep 2023.
    • 16 Jul 2019 Status changed from recruiting to active, no longer recruiting.
    • 14 Oct 2018 This trial has been completed in Germany.
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