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