NCT04799496Completed
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Kynteles Injection (Vedolizumab) for the Approved Indications in South Korea
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice. The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 688 (actual)
- First submitted
- 15 Mar 2021
- Start date
- 10 Jun 2020
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04799496
What you commit to
- Study type: Observational
- Participants enrolled: 688
- From 10 Jun 2020 to the primary completion date, 30 Jun 2025
- 43 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.
Other illness
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
- With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
Who the study is looking for
- With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soon Chunhyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Good Gang-An Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Soonchunhyang University Cheonan Hospital Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Hallym Univ. Medical Center Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| Kangwon National University Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| Koo Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Daegu Patima Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Hanyang University Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| The Catholic University of Korea, Bucheon ST. Marys Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| DongGuk University International Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Unknown status |
| Ilsan Paik Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| CHA University Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyunghee university hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Inje University Sanggye Paik Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Nowon Eulji Medical Center, Eulji University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| KyungHee University Hospital at GangDong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.