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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 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 2,415-participant average among 104 other Crohn's Disease trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02559713
The ClinicalTrials.gov registry entry for NCT02559713 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,415-participant average among 104 other Crohn's Disease trials with a reported enrollment target (100% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.