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COMPLETED
NCT03196427
PHASE2

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2018-07-30

Completion Date

2025-07-17

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Vedolizumab

Vedolizumab intravenous infusion

Locations (23)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours Childrens Specialty Care - Jacksonville

Jacksonville, Florida, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Columbia University Medical Center

New York, New York, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Hopital Necker-Enfants Malades

Paris, Île-de-France Region, France

BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

Miskolc, Borsod-Abauj Zemplen county, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petach Tiqwa, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

Rzeszów, Podkarpackie Voivodeship, Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

Lodz, Łódź Voivodeship, Poland

Kharkiv Regional Clinical Children's Hospital

Kharkiv, Ukraine

Barts and The London NHS Trust

London, England, United Kingdom