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A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Sponsor: Takeda
Summary
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Official title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2023-05-16
Completion Date
2033-02-07
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Vedolizumab IV
Vedolizumab IV infusion
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Locations (98)
University of South Alabama (USA) Physicians Group
Mobile, Alabama, United States
Phoenix Childrens Hospital - Thomas Rd - PIN
Phoenix, Arizona, United States
Cedars Sinai Medical Center - 127 San Vicente Blvd
Los Angeles, California, United States
Rady Children's Hospital - San Diego - PIN
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
I.H.S Health LLC-Kissimmee-445 W Oak St
Kissimmee, Florida, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States
Advocate Children's Hospital - Park Ridge - PIN
Park Ridge, Illinois, United States
Riley Hospital For Children - PIN
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital - PIN
Boston, Massachusetts, United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN
New Hyde Park, New York, United States
University of Rochester Medical Center - PPDS
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland, Ohio, United States
UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN
Pittsburgh, Pennsylvania, United States
Hasbro Children's Hospital - PIN
Providence, Rhode Island, United States
Texas Children's Hospital - Baylor - PIN
Houston, Texas, United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
UZ Antwerpen - PIN
Edegem, Antwerpen, Belgium
UZ Brussel - PIN
Jette, Brussels Capital, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital - 4480 Oak St
Vancouver, British Columbia, Canada
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, China
Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus
Zhengzhou, Henan, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus
Hangzhou, Zhejiang, China
Children's Hospital Zagreb
Zagreb, City of Zagreb, Croatia
University Hospital Center Zagreb
Zagreb, City of Zagreb, Croatia
University Hospital of Split-Spinciceva 1
Split, Croatia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, Czechia
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, Czechia
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Athens, Attica, Greece
Children's Hospital Agia Sofia
Athens, Greece
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, Hungary
Clinexpert Obuda Egeszsegcentruma
Budapest, Hungary
Semmelweis Egyetem, Pulmonologiai Klinika
Budapest, Hungary
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Jerusalem, Jerusalem, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Soroka University Medical Centre
Beersheba, Israel
Rambam Health Care Campus PPDS
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Israel
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, Israel
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2
Naples, Campania, Italy
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy
Sapienza University of Rome
Rome, Lazio, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy
Azienda Ospedaliero Universitaria A Meyer
Florence, Tuscany, Italy
Universita degli Studi di Padova
Padova, Veneto, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Saitama Children's Medical Center-1397-1 yamane
Hidaka, Saitama, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, Lithuania
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
Gdansk, Pomeranian Voivodeship, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia SCM - Slowackiego
Szczecin, West Pomeranian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
Lodz, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorob
Bratislava, Slovakia
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Sant Joan de Deu - PIN
Barcelona, Spain
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, Spain
Hospital Regional Universitario de Malaga Hospital Materno-Infantil
Málaga, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Great Ormond Street Hospital
London, London, City of, United Kingdom
Noahs Ark Childrens Hospital for Wales - PIN
Cardiff, South Glamorgan, United Kingdom
King's College Hospital
London, Surrey, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, Warwickshire, United Kingdom
Barts Health NHS Trust - PPDS
London, United Kingdom
Royal Manchester Children's Hospital - PPDS - PIN
Manchester, United Kingdom