JPRN-jRCTs031210156已完成3 期
Evaluation of Efficacy and Safety of Cholestimide for Diarrhea in Patients with ATTRv Amyloidosis
Yoshiki Sekijima0 个研究点目标入组 9 人开始时间: 2021年6月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
Increased production and secretion of bile acids are associated with diarrheal symptoms in patients with ATTRv amyloidosis. Cholestimide significantly reduces the frequency of diarrhea in patients with ATTRv amyloidosis. Further studies in larger cohorts are warranted.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients aged 20 years or older with a diagnosis of ATTRv amyloidosis
- •2) Patients with diarrhea symptoms that are difficult to control with existing symptomatic medications for diarrhea (Bristol Stool Shape Scale 6 or higher)
- •3) Patients who are able to comply with their medication and keep an appropriate diary.
- •4) Patients who have given written consent based on the free will of the subject after receiving sufficient explanation for participation in this study.
排除标准
- •Patients who do not meet any of the following exclusion criteria will be included.
- •(1) Patients for whom consent cannot be obtained
- •(2) Patients who have contraindications to the use of the study drug (patients with complete obstruction of the biliary tract, patients with intestinal obstruction, patients with a history of hypersensitivity to the components of Corevine Tablets 500 mg).
- •(3) Other patients who are judged by the principal investigator to be unsuitable as subjects.
研究者
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