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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
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

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Soon Chunhyang University Hospital Bucheon
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Bucheon-siSouth KoreaUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Good Gang-An Hospital
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BusanSouth KoreaUnknown status
Inje University Busan Paik Hospital
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BusanSouth KoreaUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Soonchunhyang University Cheonan Hospital
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CheonanSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Hallym Univ. Medical Center
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ChuncheonSouth KoreaUnknown status
Kangwon National University Hospital
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ChuncheonSouth KoreaUnknown status
Koo Hospital
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DaeguSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Yeungnam University Medical Center
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DaeguSouth KoreaUnknown status
Kyungpook National University Hospital
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DaeguSouth KoreaUnknown status
Daegu Patima Hospital
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DaeguSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
The Catholic University of Korea, Daejeon ST.Mary's Hospital
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DaejeonSouth KoreaUnknown status
Chosun University Hospital
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GwangjuSouth KoreaUnknown status
Hanyang University Medical Center
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Gyeonggi-doSouth KoreaUnknown status
The Catholic University of Korea, Bucheon ST. Marys Hospital
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Gyeonggi-doSouth KoreaUnknown status
Korea University Ansan Hospital
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Gyeonggi-doSouth KoreaUnknown status
Inje University Ilsan Paik Hospital
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Gyeonggi-doSouth KoreaUnknown status
DongGuk University International Hospital
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IlsanSouth KoreaUnknown status
Ilsan Paik Hospital
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IlsanSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
CHA University Bundang Medical Center
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SeongnamSouth KoreaUnknown status
Chung ang University Hospital
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SeoulSouth KoreaUnknown status
Kyunghee university hospital
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SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Inje University Sanggye Paik Hospital
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SeoulSouth KoreaUnknown status
Nowon Eulji Medical Center, Eulji University
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
KyungHee University Hospital at GangDong
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Wonju Severance Christian Hospital
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WŏnjuSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.