NCT02690025已完成2 期
A Phase 2 Trial Testing ZP1848 in Patients With SBS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.
研究概览
简要总结
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
- •Age ≥ 18 years and ≤ 90 years
- •Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago
- •A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS
- •Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study.
- •Stable body weight (<5% weight deviance in the three months prior to screening)
排除标准
- •Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator
- •Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator.
- •Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization
- •Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
- •History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded)
- •eGFR (by the MDRD formula) <30 mL/min/1.73 m2
- •Clinically meaningful renal disease as judged by the Investigator
研究组 & 干预措施
ZP1848 High dose
Experimental
s.c. administration of high dose
干预措施: ZP1848 (Drug)
ZP1848 Medium dose
Experimental
s.c. administration of medium dose
干预措施: ZP1848 (Drug)
ZP1848 Low dose
Experimental
s.c. administration of low dose
干预措施: ZP1848 (Drug)
结局指标
主要结局
The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.
时间窗: 3 weeks
次要结局
- Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods(3 weeks)
- Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods(3 weeks)
- Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods(3 weeks)
- Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods(3 weeks)
- Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods(3 weeks)
- Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods(3 weeks)
- Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods(3 weeks)
- Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods(3 weeks)
- Incidence of Anti Drug Antibodies(15 weeks)
- Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods(3 weeks)
- Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods(3 weeks)
- Change in SF-36 score(3 weeks)
- Incidence of Adverse Events(15 weeks)
- Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods(3 weeks)
研究者
研究点 (1)
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