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An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

Trial Profile

An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 09 Feb 2021

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease; Inflammatory bowel diseases; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Takeda

Most Recent Events

  • 05 Feb 2021 Results published in the Clinical Pharmacokinetics
  • 19 May 2020 Results published in Gasteroenterology in conjunction with Digestive Disease Week 2020.
  • 22 Feb 2019 Status changed from active, no longer recruiting to completed.

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