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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: Completed Phase 2 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AE defined as any untoward medical occurrence in clinical investigation participants administered drug; it does not necessarily have to have causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it was considered related to the drug. TEAE was defined as an AE whose date of onset occurred on or after the firs
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 |
What the finished NCT03196427 record still lists
NCT03196427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03196427's enrollment target sits among peer trials
59 81st of 122 higher than 41 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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