Extension trial to evaluate long-termefficacy and safety of glepaglutide in patients with short bowel syndrome

Phase 1

• Conditions: Short bowel syndrome; MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001429-26-PL
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Patients rolling over from the lead-in trial:
The patient must meet all of the following inclusion criteria:
- Signed informed consent
Either of the following:
- Completed the full Treatment Phase of the lead-in trial (ZP1848-17111), regardless of treatment adherence.
OR
b) Eligible based on the same inclusion/exclusion criteria as in the lead-in trial (patients may be
directly screened into this trial)
Patients screened directly to the Extension Trial
The patient must meet all of the following inclusion criteria:
1. Informed consent obtained before any trial-related activity.
2. Age = 18 years and = 90 years at Screening.
3. 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.
4. Requiring PS at least 3 days per week.
5. Willing to adhere to an individual pre-defined drinking menu during 48-hours measuring intervals.
6. Willing to maintain a stable weight (± 5%) for the duration of the trial (24 weeks).
7. Having:
a. A stoma Or
b. Colon-in-Continuity (CiC) with documented colonoscopy performed during Screening and which does not give rise to any safety concerns.
Note: A colonoscopy performed within 6 months prior to Screening and not giving rise to any safety concerns is acceptable. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) (if standard of care at site) will suffice at the discretion of the Investigator.
8. Having:
a) a stoma Or
b) colon-in-continuity (CiC) and able to separate stool and urine during the 48 hours measuring intervals.
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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Patients rolling over from the lead-in trial
The patient must be excluded from this trial if any of the following criteria are met:
- Withdrew consent from lead-in or Phase 2 trial.
- Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confounds planned assessments of the trial.
- Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4), inhibitors, citrulline, somatostatin, or analogs thereof within 3 months. Note: Prior glepaglutide trial drug is allowed.
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Highly effective contraception methods and definition of child-bearing potential are described in Section 11.4.4 of there Study Protocol.
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- An employee of the sponsor or Investigator or otherwise dependent on them.
Patients screened directly to the Extension Trial
The patient must be excluded from the trial if he or she meets any of the following criteria:
1. 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.
2. Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
3. Bowel obstruction.
4. Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease.
5.Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and.
6. Clinically significant abnormal ECG as judged by the Investigator.
7. Repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure measurements > 180 mm Hg.
8. Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease.
9. 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.
10. Estimated creatinine clearance (CrCL; by the Cockcroft-Gault formula) < 30 mL/min.
11. 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
12. Use of GLP-1, GLP-2, HGH, somatostatin, or analogs thereof, within 3 months prior to Screening.
13. Use of DPP-4 inhibitors within 3 months prior to Screening.
14. Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening.
15. Unstable biological therapy (e.g. anti-tumor necrosis factor alpha [TNF-a], natalizumab, etc.) within 6 months prior to Screening, including significant changes in doses or switch of drug.
16. Females of childbearing potential, who are pregnant, breastfeeding, intend to become pregnant or are not using highly effective contraceptive methods. Highly effective contraception methods and
definition of child-bearing potential are described in Section 11.4.4.
17. Known or suspected hypersensitivity to glepaglutide or related products.
18. Previous expo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified