A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Recruiting now · Phase 3
Conditions studied: Ulcerative Colitis, Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT05442567
- Run by
- Takeda
- People needed
- 240
- Starts
- 2023-05-16
- Expected to finish
- 2033-02-07
- Last updated by the study team
- 2026-05-07
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Agia Sofia — Athens, Greece (enrolling)
- Hadassah Medical Center- Ein Kerem - PPDS — Jerusalem, Israel (enrolling)
- Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus — Zhengzhou, Henan, China (enrolling)
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Athens, Attica, Greece (enrolling)
- Tel Aviv Sourasky Medical Center Ichilov - PPDS — Jerusalem, Jerusalem, Israel (enrolling)
- Carmel Medical Center — Haifa, Israel (enrolling)
- UZ Antwerpen - PIN — Edegem, Antwerpen, Belgium (enrolling)
- UZ Leuven — Leuven, Vlaams Brabant, Belgium (enrolling)
- The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus — Hangzhou, Zhejiang, China (enrolling)
- Children's Hospital Zagreb — Zagreb, City of Zagreb, Croatia (enrolling)
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz — Miskolc, Borsod-Abauj Zemplen county, Hungary (enrolling)
- Semmelweis Egyetem, Pulmonologiai Klinika — Budapest, Hungary (enrolling)
- Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel (enrolling)
- Rambam Health Care Campus PPDS — Haifa, Israel (enrolling)
- Advocate Children's Hospital - Park Ridge - PIN — Park Ridge, Illinois, United States (enrolling)
- Royal Children's Hospital Melbourne - PIN — Parkville, Victoria, Australia (enrolling)
- Phoenix Childrens Hospital - Thomas Rd - PIN — Phoenix, Arizona, United States (enrolling)
- UZ Brussel - PIN — Jette, Brussels Capital, Belgium (enrolling)
- Hunan Children's Hospital — Changsha, Hunan, China (enrolling)
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Carilion Children's Tanglewood Center — Roanoke, Virginia, United States (enrolling)
- Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)
- Queensland Childrens Hospital — South Brisbane, Queensland, Australia (enrolling)
- General Hospital of Thessaloniki ''Hippokratio'' — Thessaloniki, Greece (enrolling)
- Azienda Ospedaliera Universitaria Federico II — Naples, Campania, Italy (enrolling)
Full record on ClinicalTrials.gov
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