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Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

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Trial Profile

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Darvadstrocel (Primary)
  • Indications Crohn's disease; Fistula; Rectal fistula
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms EMPIRE
  • Sponsors Takeda; Takeda Oncology

Most Recent Events

  • 17 Mar 2025 Status changed from active, no longer recruiting to discontinued, as per sponsor's decision.
  • 25 Sep 2023 Status changed from recruiting to active, no longer recruiting.
  • 13 Aug 2021 Planned End Date changed from 28 Feb 2026 to 31 Mar 2026.

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