EUCTR2019-003987-37-SI进行中（未招募）1 期
Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens
niversity Medical Centre Ljubljana, Department of gastroenterology0 个研究点目标入组 30 人开始时间: 2019年11月27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
- 性别
- All
入选标准
- •1) Histologicaly confirmed ulcerative colitis
- •2) age <18 years old
- •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) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.
- •2) Active tuberculosis or other opportunistic bacterial, viral and fungal infections.
- •3) History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure .
- •4) Pregnancy.
研究者
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