jRCT2021210005已完成不适用
A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VectivBio AG
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male and female subjects with SBS-IF, receiving PS,
- •secondary to surgical resection of the small intestine
- •with <200 cm from duodeno-jejunal flexure, based on
- •available medical/surgical records and with either:
- •a. CIC and neither jejunostomy nor ileostomy with
- •the latest intestinal resection being at least
- •12 months prior to screening OR
- •b. Jejunostomy or ileostomy with the latest
- •intestinal resection being at least 6 months
- •prior to screening.
排除标准
- •Major abdominal surgery (more than 10% intestinal
- •resection or surgery that changes anatomy group) in
- •the last 6 months prior to screening. Surgery for
- •feeding tube placement allowed.
结局指标
主要结局
-
Relative change from baseline in actual weekly PS volume at Week 24
次要结局
- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 24(Week 24)
- Relative change from baseline in actual weekly PS volume at Week 24 in stoma subjects(Week 24)
- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 48 in CIC subjects(Week 48)
- CIC subjects reaching enteral autonomy at Week 48(Week 48)
研究者
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