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
This Study is
No Longer Enrolling
The safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk.
MoreAdult
18 years or older Physician has prescribed vedolizamub and is the patient is on established vedolizumab maintenance therapy and received at least 1 dose o 300mg of vedolizumab Diagnosed with UC or Crohn's 5 weeks of postpartum Lactation is established and mother is exclusively breast-feeding infant
Diagnosed with Crohn's or ulcerative colitis Currently taking vedolizumab Females only Subject must be breast-feeding
IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
Treatment
University of Colorado Hospital
Protocol Number: 16-0066
More information available at ClinicalTrials.gov: NCT02559713
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