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NCT03196427 · ClinicalTrials.gov registry record · Phase 2
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 2 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT03196427 is a Phase 2 study of Ulcerative Colitis and Crohn's Disease that has completed, run by Takeda. The registered enrollment target is 59 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT03196427, a Phase 2 study of Ulcerative Colitis and Crohn's Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Conditions Studied
Interventions
- DRUG Vedolizumab
Study Locations (20)
Other
- Carmel Medical Center - Haifa
- Shaare Zedek Medical Center - Jerusalem
- Schneider Children's Medical Center of Israel - Petach Tiqwa
- Tel Aviv Sourasky Medical Center - Tel Aviv
California
- Cedars-Sinai Medical Center - Los Angeles
- Children's Hospital of Orange County - Orange
- University of California San Francisco - San Francisco
Connecticut
- Connecticut Children's Medical Center - Hartford
Florida
- Nemours Childrens Specialty Care - Jacksonville - Jacksonville
Georgia
- Children's Center for Digestive Healthcare - Atlanta
New York
- Columbia University Medical Center - New York
Texas
- Texas Children's Hospital - Houston
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2025-07-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03196427
The ClinicalTrials.gov registry entry for NCT03196427 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab is the first listed.
NCT03196427 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03196427 about?
NCT03196427 is a clinical study titled "Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)". The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
What is the current status of trial NCT03196427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2018-07-30. Estimated completion is 2025-07-17.
What conditions does trial NCT03196427 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease.
What interventions are being tested in trial NCT03196427?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT03196427?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03196427 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, New York. 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.