Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
| 适应症 | Ulcerative Colitis, Crohn's Disease |
|---|---|
| 分期 | 2期 |
| 申办方 | Takeda |
| 状态 | 已完成 |
| 受试者人数 | 59 人 |
| 干预（药物） | Vedolizumab |
| 开始日期 | 2018年7月30日 |
| 完成日期 | 2025年4月3日 |
| 结果公布日 | 2026年3月13日 |
摘要
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 |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severe — Janssen Research & Development, LLC
- A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
- A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
- Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW