Controlled trial to evaluate the efficacy and safety of glepaglutide in patients with short bowel syndrome
- Conditions
- Short bowel syndromeMedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-004394-14-FR
- Lead Sponsor
- Zealand Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 129
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation are provided in section E.5.1 aside endpoints;Main Objective: To confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.;<br> Secondary Objective: To evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS.<br> To evaluate the safety and tolerability of glepaglutide in patients with SBS.<br> ;Primary end point(s): Clinical response, defined as achieving at least 20% reduction in weekly PS volume from baseline to both Weeks 20 and 24
- Secondary Outcome Measures
Name Time Method