At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 11 enrolled
Drug / intervention
Vedolizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Vedolizumab for Colitis, Ulcerative and Crohn's Disease. Completed, enrolled 11 participants across 7 sites.
Detailed Summary
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative, Crohn's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartNov 2017
Primary CompletionFeb 2019
TodayJul 2026
First PostedSep 24, 2015
Enrollment StartNov 29, 2017
Primary CompletionFeb 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.8 years ago
Interventions
Vedolizumabdrug
Vedolizumab IV infusion