EUCTR2020-004612-97-DE进行中（未招募）1 期
A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Signed informed consent,
- •Men or women between 18 and 80 years of age, inclusively,
- •Documented initial biopsy proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA > 10 x upper limit
- •of normal (ULN) at diagnosis at least 12 months prior to V0
- •Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
- •Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
- •At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to Baseline Visit A, Visit 2, and Baseline Visit B
- •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 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Presence of hypo- or hyperthyroidism
- •Subjects diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells and if they do not present with very severe symptoms and/or parameters of significant malabsorption
- •and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine,
- •Severe complications of celiac disease [e.g., enteropathy associated Tcell lymphoma (EATL), ulcerative jejunitis, perforation],
- •Concomitant diseases of the intestinal tract in addition to celiac disease that might, in the investigator's opinion, interfere with
- •assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease
- •Evidence of relevant systemic disease
研究者
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