EUCTR2018-002794-21-GB进行中（未招募）1 期
Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR
Guy's & St Thomas NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2018年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Aged 18 years or over, either male or female?
- •Moderate-to-severe UC, defined as:
- •-SCCAI > 5 and,
- •i.A raised fecal calprotectin (> 59 µg/g) or,
- •ii.A raised CRP (> 5 mg/L) or,
- •iii.Endoscopic disease activity Mayo 2 or above,
- •Evaluated within 6 weeks of study enrollment
- •Commencing vedolizumab treatment
- •Sufficient English language skills to understand the patient information sheet and consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
- •Imminent need for colectomy (i.e. colectomy is being planned)
- •Previous ileoanal pouch formation
- •Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections
研究者
相似试验
Unknown
4 期
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative ColitisUlcerative ColitisNCT04006080Guy's and St Thomas' NHS Foundation Trust30
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