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Completed Phase 2 Interventional Results available

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

ClinicalTrials.gov ID: NCT03138655

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:16 PM EDT

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

Study identification

NCT ID
NCT03138655
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
89 participants

Conditions and interventions

Interventions

  • Vedolizumab Drug

Drug

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 7, 2017
Primary completion
Mar 30, 2020
Completion
May 25, 2020
Last update posted
Dec 20, 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 20, 2020 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03138655 live on ClinicalTrials.gov.

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