Short Bowel Syndrome
Conditions
Brief summary
Safety Endpoints: Incidence and type of AEs (primary endpoint), Safety Endpoints: Incidence and type of serious adverse events (SAEs) and AESIs., Safety Endpoints: Changes from baseline in: - Vital signs -Electrocardiogram (ECG), Safety Endpoints: Changes from baseline in: -Hematology -Biochemistry -Urinalysis, Safety Endpoints: Immunogenicity, Efficacy Endpoints: Reduction in weekly PS volume from baseline, Efficacy Endpoints:Reduction of at least 20% in weekly PS volume from baseline, Efficacy Endpoints: Reduction in days on PS ≥ 1 day/week from baseline, Efficacy Endpoints: Reduction in weekly PS volume of 100% (weaned off)
Detailed description
Change in fluid composite effect (FCE) from baseline, Reduction in calculated energy content of parenteral macronutrients from baseline, Reduction in number of days on PS per week from baseline, Reduction of at least 40% in weekly PS volume from baseline, Change in weight from baseline
Interventions
DRUGGlepaglutide Placebo
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Incidence and type of AEs (primary endpoint), Safety Endpoints: Incidence and type of serious adverse events (SAEs) and AESIs., Safety Endpoints: Changes from baseline in: - Vital signs -Electrocardiogram (ECG), Safety Endpoints: Changes from baseline in: -Hematology -Biochemistry -Urinalysis, Safety Endpoints: Immunogenicity, Efficacy Endpoints: Reduction in weekly PS volume from baseline, Efficacy Endpoints:Reduction of at least 20% in weekly PS volume from baseline, Efficacy Endpoints: Reduction in days on PS ≥ 1 day/week from baseline, Efficacy Endpoints: Reduction in weekly PS volume of 100% (weaned off) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fluid composite effect (FCE) from baseline, Reduction in calculated energy content of parenteral macronutrients from baseline, Reduction in number of days on PS per week from baseline, Reduction of at least 40% in weekly PS volume from baseline, Change in weight from baseline | — |
Countries
Belgium, France, Germany, Netherlands, Poland
Outcome results
None listed