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A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Sponsor: Takeda
Summary
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
Official title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-10-27
Completion Date
2030-08-12
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
Vedolizumab SC
Vedolizumab subcutaneous injection.
No Intervention
As this is an observational cohort, no intervention will be administered.
Locations (54)
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Loma Linda University
Loma Linda, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford Children's Health
Palo Alto, California, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States
Childrens Hospital of Michigan
Detroit, Michigan, United States
Atlantic Health - Morristown Medical Center
Morristown, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
University Children's Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Penn State Health Milton South Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Multicare Health System Institute for Research and Innovation
Tacoma, Washington, United States
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Centre Hospitalier Chretien MontLegia
Liège, Belgium
UMHAT Sv. Georgi, EAD
Plovdiv, Bulgaria
Hvidovre Hospital
Hvidovre, Capital Region, Denmark
Childrens Health Ireland at Crumlin - PIN
Crumlin, Dublin, Ireland
Azienda Ospedaliera Universitaria Gaetano Martino, Messina
Messina, Italy
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN
Milan, Italy
Unita Operativa Complessa Di Pediatria Medica
Pescara, Italy
Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu
Roma, Italy
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego
Zabrze, Poland
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, Portugal
Victor Gomoiu Clinical Hospital for Children
Bucharest, Bucharest, Romania
Pius Brinzeu Emergency Clinical County Hospital
Timișoara, Timiș County, Romania
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, Romania
University Children's Clinic
Belgrade, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia
Institute for Children and Youth Health Care of Vojvodina
Novi Sad, Serbia
Kyungpook National University Chilgok hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Arquitecto Marcide de Ferrol
Ferrol, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain
University Hospital of Bern
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Changhua Christian Medical Foundation - Changhua Christian Children's Hospital
Changhua, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Zhongzheng, Taiwan