The long-term effect on intestinal absorption and safety of treatment withGlepaglutide in patients with short bowel syndrome
- Conditions
- Short bowel syndromeMedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-005194-27-DK
- Lead Sponsor
- Zealand Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
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 < 25% change in PS volume or energy
content for 4 weeks prior to screening.
5. Stable body weight (<5% change in weight in the 3 months prior to screening).
6. Wet weight of fecal excretion =1,500 g/day demonstrated during a hospital stay prior to
screening*.
*If inclusion criteria #6 cannot be met, a visit may be scheduled where fecal output collected at
home by the patient or during a hospital stay can be assessed. If the wet weight of fecal excretion
=1,500 g/day can be demonstrated, the criterion #6 is met.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method