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

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 18 Apr 2018

At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Takeda
  • Most Recent Events

    • 12 Apr 2018 Planned End Date changed from 31 Mar 2018 to 5 Feb 2019.
    • 12 Apr 2018 Planned primary completion date changed from 31 Mar 2018 to 5 Feb 2019.
    • 09 Feb 2018 Planned End Date changed from 23 Feb 2018 to 31 Mar 2018.
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