A phase 2 trial testing ZP1848 in patients with SBS

Zealand Pharma A/S0 个研究点开始时间: 2015年10月29日最近更新: 2017年10月2日

试验速览

暂无简介。

•1. 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.
•2. Age 18 years and 90 years
•3. Stable SBS patients with intestinal insufficiency or failure, where the last surgical
•resection of gut tissue was performed at least 1 year ago
•4. A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to
•randomization for patients requiring PS
•5. 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.
•6. Stable body weight (<5% weight deviance in the three months prior to screening)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•8. Patients with known or suspected intestinal strictures of clinical relevance as judged by
•the Investigator
•11. Active inflammatory bowel disease (IBD) or fistula during the screening period as judged
•by conventional means of the Investigator.
•12. Crohn’s disease patients not being in clinical remission for the last 12 weeks prior to
•randomization
•13. 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
•15. 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)
•20. eGFR (by the MDRD formula) <30 mL/min/1.73 m2
•21. Clinically meaningful renal disease as judged by the Investigator

发起方

Zealand Pharma A/S