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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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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: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Sep 2024

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At a glance

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

    • Most Recent Events

    • 14 Sep 2024 This trial has been discontinued in Poland, according to European Clinical Trials Database record.
    • 01 Nov 2023 Status changed from active, no longer recruiting to discontinued due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.
    • 05 Oct 2023 This trial has been discontinued in Spain, according to the European Clinical Trials Database record.

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