Vedolizumab for the Treatment of Collagenous Gastritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in symtpoms
研究概览
简要总结
The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:
- Whether vedolizumab can reduce CG symptoms
- Whether vedolizumab is safe to take for patients with CG
Participants in this study will:
- Receive vedolizumab through an IV ("infusion")
- Complete a survey at each infusion visit
- Have blood collected at each infusion visit
- Undergo an endoscopy with biopsy at 2 timepoints
详细描述
Eligible participants will receive vedolizumab through an IV ("infusion") at week 0, then week 2, then week 6. Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year. At each visit, participants will be asked about their collagenous gastritis symptoms and any changes in their health or medications.
Blood samples will be collected from participants at every vedolizumab infusion. Some of these samples will be collected for safety purposes, some will be collected to monitor CG progression, and some will be collected for research purposes.
During the screening period and a few months after beginning treatment, the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participant's CG. An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract (the esophagus, stomach, and part of the small intestine). During the procedure, biopsies will be collected to monitor CG and for research purposes. All participants will be given medication to make them comfortable throughout the duration of the procedure, which lasts approximately 10 to 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 or older
- •Weight of at least 40kg
- •Has a biopsy-confirmed diagnosis of collagenous gastritis
- •Agrees to all required study procedures
- •Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash
排除标准
- •Unable to independently provide informed consent or assent
- •Allergic to vedolizumab or any of its components
研究组 & 干预措施
Vedolizumab 300mg
- Dose: 300mg
- Administration: Intravenous (IV)
- Frequency: Weeks 0, 2, 6, and then every 8 weeks
- Duration: 54 weeks (1 year)
干预措施: Vedolizumab (Biological)
结局指标
主要结局
Change in symtpoms
时间窗: 12 Weeks
Change in symptoms associated with collagenous gastritis after 12 weeks of vedolizumab treatment, measured via patient-reported symptom questionnaire scores collected at each visit. Response is defined as a decrease of at least 1 Grade (DAIDS) in the most severe symptom reported at baseline. Surveys will be scored from 0 to 38, with higher scores indicating more severe symptoms and lower outcomes indicating no symptoms or more mild symptoms.
次要结局
- Histologic response(12 weeks (+/- 4 weeks))
- Response durability(54 Weeks)
- Incidence of treatment-emergent adverse events (safety)(54 Weeks)
研究者
Michael Dougan
Associate Professor of Medicine
Massachusetts General Hospital