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Clinical trial

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

NCT02559713 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Takeda
Phase
Phase 4
Overall status
Completed
Start date
November 29, 2017
Completion date
February 22, 2019
Enrollment
11 (actual)
Sites
7

Conditions

As the registry lists them; a condition with its own page is linked.

colitis, ulcerative, crohn's disease