Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
| Заболевание | Ulcerative Colitis, Crohn's Disease |
|---|---|
| Фаза | Фаза 2 |
| Спонсор | Takeda |
| Статус | Завершено |
| Участники | 59 участн. |
| Вмешательство | Vedolizumab |
| Дата начала | 30.07.2018 |
| Дата завершения | 3.04.2025 |
| Публикация результатов | 13.03.2026 |
Кратко
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 |
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Другие исследования по этому заболеванию
- 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