EUCTR2017-002241-30-IE进行中（未招募）1 期
A phase IIa, double-blind, randomised, placebo-controlled, dose-finding study on the efficacy and tolerability of a 6-week treatment with ZED1227 capsules vs. placebo in subjects with well-controlled celiac disease undergoing gluten challenge - ZED1227 capsules vs. placebo in celiac disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Documented initial biopsy proven diagnosis of celiac disease at least 12 months prior to screening,
- •Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
- •Negative TG2-IgA serology
- •Successful adherence to a gluten-free diet for at least 12 months
- •Negative diagnosis of Helicobacter pylori infection
- •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 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Selective immunoglobulin A deficiency,
- •IgE-specific antibodies against wheat or gliadin
- •Refractory celiac disease defined as persistent or recurrent malabsorptive symptoms and signs
- •Severe complications of celiac disease
- •Any concomitant diseases of the intestinal tract in addition to celiac disease
- •Diabetes mellitus type 1
- •Evidence of relevant systemic disease
研究者
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