Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
| 대상 질환 | Ulcerative Colitis, Crohn's Disease |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | Takeda |
| 상태 | 완료 |
| 참여자 수 | 59 명 |
| 중재(약물) | Vedolizumab |
| 시작일 | 2018년 7월 30일 |
| 완료일 | 2025년 4월 3일 |
| 결과 공개일 | 2026년 3월 13일 |
요약
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
| UC Participants (< 30 kg): Vedolizumab 100 mg | 100 percentage of participants |
|---|---|
| UC Participants (< 30 kg): Vedolizumab 200 mg | 83.3 percentage of participants |
| CD Participants (< 30 kg): Vedolizumab 100 mg | 100 percentage of participants |
| CD Participants (< 30 kg): Vedolizumab 200 mg | 100 percentage of participants |
| UC Participants (>=30 kg): Vedolizumab 150 mg | 100 percentage of participants |
| UC Participants (>=30 kg): Vedolizumab 300 mg | 100 percentage of participants |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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