A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide in patients with short bowel syndrome (SBS) - Ease SBS 1 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS

Zealand Pharma A/S0 个研究点目标入组 129 人开始时间: 2018年9月4日最近更新: 2019年4月30日

研究概览

暂无简介。

•Age = 18 years and = 90 years at Screening.
•Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm [equal to 79 inches] and with the latest intestinal resection being at least 6 months prior to Screening and considered stable with regard to PS need. No restorative surgery planned in the trial period.
•Requiring PS at least 3 days per week.
•Willing to adhere to an individual pre-defined drinking menu during 48-hours measuring intervals.
•Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks. PS volume is considered stable if all of the criteria below are fulfilled:
•- Actual PS usage (volume and content) matches prescribed PS (± 10% deviation in
•volume is acceptable)
•- 48-hour urine volumes at 2 consecutive visits within a 2-week interval (± 4 days, i.e., visits should be 10 to 18 days apart) are similar (a maximum of ± 25% deviation is acceptable), while the oral fluid intake is constant (the two 48-hour oral intakes differ less than 10%) and maximum 3.5 L per day
•- Urine volume must be = 1 L per day and = 2.5 L per day
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 39

•More than 2 SBS-related or PS-related hospitalizations (e.g., catheter related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to Screening.
•Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.
•Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years.
•Estimated creatinine clearance (CLcr; by the Cockcroft-Gault formula) < 30 mL/min.
•Hepatic impairment defined as:
•-Total bilirubin = 2 × the upper limit of normal (ULN), or
•-Aspartate aminotransferase (AST) = 5 × ULN)
•-Alanine aminotransferase (ALT) = 5× ULN
•Use of GLP-1, GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to Screening.

发起方

Zealand Pharma A/S