Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Public ClinicalTrials.gov record NCT03138655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
Study identification
- NCT ID
- NCT03138655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 8, 2017 (Actual)
- Primary completion
- Mar 31, 2020 (Actual)
- Completion
- May 26, 2020 (Actual)
- Last update posted
- Dec 21, 2020
2017 – 2020
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California San Francisco | San Francisco | California | 94143-0135 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106-3322 | — |
| Nemours Children's Clinic | Wilmington | Delaware | 19803 | — |
| Nemours Childrens Specialty Care - Jacksonville | Jacksonville | Florida | 32207 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Children's Center for Digestive Healthcare | Atlanta | Georgia | 30342 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | — |
| Indiana University School of Medicine - Indianapolis | Indianapolis | Indiana | 46202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905-0001 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10031 | — |
| The Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| University Hospitals Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Childrens Medical Center of Dallas | Dallas | Texas | 75235 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84113 | — |
| Children's Specialty Group - Medical Center Location | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03138655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2020 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03138655 live on ClinicalTrials.gov.