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临床试验/NCT07257835
NCT07257835招募中不适用

Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Endoscopic response rate

研究概览

简要总结

This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.

详细描述

Eosinophilic Gastrointestinal Disorders (EGIDs) are chronic inflammatory diseases caused by extensive infiltration of eosinophils in the gastrointestinal tract. Treatment requires long-term dietary avoidance, long-term oral administration of high-dose omeprazole, as well as hormones and immunosuppressants, but the results are unsatisfactory and the side effects are significant. Dupilumab is a fully human monoclonal antibody (IgG4 type) that can specifically bind to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes to inhibit the signal transduction of IL-4 and IL-13. Current studies have shown that subcutaneous treatment with dupilumab for eosinophilic esophagitis has significant efficacy. In recent years, this drug has been reported to be used for various forms of gastrointestinal diseases such as eosinophilic gastritis, duodenitis, etc., with remarkable efficacy. In recent years, there has been an increasing number of children with refractory eosinophilic gastrointestinal diseases, which can easily cause repeated large ulcers, perforation, and stenosis in the gastrointestinal tract, requiring surgical intervention. This disease seriously affects the growth and development of children and urgently requires better treatment options. This study aims to evaluate the efficacy and tolerance of dupilumab in children with refractory eosinophilic gastrointestinal diseases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Refractory Peptic Ulcers
  • with Refractory Eosinophilic Gastrointestinal Disorders

排除标准

  • with Active Helicobacter pylori infection at present.
  • with Inflammatory bowel disease
  • with Parasite infection
  • with Cancer

研究组 & 干预措施

The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump

干预措施: Dupilumab - Standard Dose (Drug)

The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump

干预措施: subcutaneous injection (Device)

结局指标

主要结局

Endoscopic response rate

时间窗: week12, week26, week52

The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.

次要结局

  • Relative Change of Peak Eosinophil Counts in the Stomach(week12,week26,week52)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying HUANG

Head of gastroenterology department

Children's Hospital of Fudan University

研究点 (1)

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