Short bowel syndrome MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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) and - 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, and - Urine volume is on average = 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.;Secondary Objective: To evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS. To evaluate the safety and tolerability of glepaglutide in patients with SBS.;Primary end point(s): Reduction in weekly PS volume from baseline to Week 24;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation are provided in section E.5.1 aside endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: ? Clinical response, defined as achieving at least 20% reduction in weekly PS volume from baseline to both Weeks 20 and 24 ? Reduction in days on PS = 1 day/week from baseline to Week 24 ? Reduction in weekly PS volume from baseline to Week 12 ? Reduction in weekly PS volume of 100% (weaned off) at Week 24 Secondary efficacy endpoints: ? Reduction of at least 20% in PS volume from baseline to both Weeks 12 and 24 ? Change in fluid composite effect (FCE) from baseline to Week 24 ? Reduction in calculated energy content of parenteral macronutrients from baseline to Week 24 ? Reduction in number of days on PS per week from baseline to Week 24 ? Reduction of at least 40% in PS volume from baseline to both Weeks 20 and 24 ? PGIC improvement at Weeks 12, 20, and 24 ? Change in weight from baseline to Week 24;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation are provided in section E.5.2 aside endpoints | — |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, United Kingdom, United States
Contacts
Public ContactTina Egegaard (CT Manager)
Zealand Pharma A/S
Outcome results
None listed