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NCT02559713 · ClinicalTrials.gov registry record · Phase 4
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
A Phase 4 study of Crohn's Disease and Colitis, Ulcerative, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 7
- Study locations
NCT02559713: Completed Phase 4 study of Crohn's Disease and Colitis, Ulcerative, sponsored by Takeda.
NCT02559713 is a Phase 4 study of Crohn's Disease and Colitis, Ulcerative that has completed, run by Takeda. The registered enrollment target is 11 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02559713, a Phase 4 study of Crohn's Disease and Colitis, Ulcerative, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).
Conditions Studied
Interventions
- DRUG Vedolizumab
Study Locations (7)
Illinois
- Feinberg School of Medicine Northwestern University - Chicago
- Carle Foundation Hospital - Urbana
Colorado
- University of Colorado - Aurora
New Jersey
- Atlantic Health System - Morristown
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2019-02-22 |
| Phase | Phase 4 |
What the finished NCT02559713 record still lists
NCT02559713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab is the first listed.
NCT02559713 lists 7 locations in 6 states (Illinois, Colorado, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02559713 about?
NCT02559713 is a clinical study titled "Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease". 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.
What is the current status of trial NCT02559713?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2017-11-29. Estimated completion is 2019-02-22.
What conditions does trial NCT02559713 study?
This clinical trial studies the following conditions: Crohn's Disease, Colitis, Ulcerative.
What interventions are being tested in trial NCT02559713?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT02559713?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02559713 being conducted?
This trial has 7 study locations across Colorado, Illinois, New Jersey, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02559713's enrollment target sits among peer trials
11 105th of 105 higher than 1 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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