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: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Age = 18 years and = 90 years at screening. 3. Willing to comply with trial procedures, including 2 in-house visits with urine and fecal output collection. 4. Stable condition of SBS either with intestinal failure (IF) or intestinal insufficiency. For patients with SBS-IF a stable condition is defined as =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: General 1. Current, or within 30 days prior to screening, participation in another interventional clinical trial that includes administration of an active compound. 2. Mental incapacity or language barriers which preclude adequate understanding or cooperation, or unwillingness to comply with trial requirements. 3. Previous participation in this trial. Participation is defined as having received trial product. 4. Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. Male patients with female partners, who intend to become pregnant. Medical history and concomitant diseases 5. 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. 6. Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial. 7. Current bowel obstruction. 8. Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease. 9. 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. 10. Clinically significant abnormal electrocardiogram (ECG) as judged by the Investigator. 11. Human immunodeficiency virus (HIV) positive, acute liver disease including positive results for Hepatitis B antigens (HBsAg) and Hepatitis C (HCV), or unstable chronic liver disease. 12. 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. 13. Hepatic impairment defined as: a. Total bilirubin = 2 × the upper limit of normal (ULN), or b. Aspartate aminotransferase (AST) = 5 × ULN, or c. Alanine aminotransferase (ALT) = 5× ULN 14. Use of GLP-1, GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening. 15. Known or suspected hypersensitivity to glepaglutide, its components or related products. 16. Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to screening. 17. Surgical resection of gut tissue within 6 months prior to screening. 18. Systemic immunosuppressive therapy for treatment of the gastrointestinal tract that has been introduced or has been unstable within 3 months prior to screening. 19. Unstable biological therapy (e.g. anti-TNF-a, natalizumab, etc.) within 6 months prior to screening, including significant changes in doses or switch of drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate the 24-week effect of glepaglutide on the absorption of fluids. ;Secondary Objective: 1. To assess the effects of glepaglutide on absorption of energy, absorption of the individual macronutrients and absorption of electrolytes. 2. To evaluate the long-term efficacy of glepaglutide in patients with SBS. 3. To describe the long-term safety of glepaglutide.;Primary end point(s): 1. Absorption of wet weight/fluids: Change from baseline to Week 24 assessed by 48-hour metabolic balance studies.;Timepoint(s) of evaluation of this end point: week 0 (baseline) and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Absorption of energy (oral intake minus fecal excretion): Change from baseline to Week 24 measured by 48-hour metabolic balance studies. Energy absorption is measured by bomb calorimetry. Secondary efficacy endpoints: 2. Absorption of individual macronutrients (carbohydrates, lipids and proteins): Change from baseline to Week 24 measured by 48-hour metabolic balance studies. 3. Absorption of electrolytes (sodium, potassium, calcium and magnesium): Change from baseline to Week 24 measured by 48-hour metabolic balance studies. For patients with SBS-IF only: 4. Weekly PS volume: Change from baseline to Week 12 and 24. 5. Weekly PS macronutrients (carbohydrates, lipids and proteins) and electrolytes (sodium, potassium and magnesium): Change from baseline to Week 12 and 24. Safety endpoints: 6. Treatment-emergent AEs until follow-up at Week 56. 7. Immunogenicity (anti-glepaglutide antibodies, reactivity to ZP18481-34, cross-reactivity to glucagon-like peptide [GLP]- 2, glepaglutide neutralizing antibodies) at baseline (W0), Week 4, 12, 24, 52, and 56.;Timepoint(s) of evaluation of this end point: From week 0 to week 56 (visit 1-12 plus follow up) | — |
Countries
Denmark
Contacts
Public ContactMikkel Askjær Agersnap
Zealand Pharma A/S
Outcome results
None listed