Status:
UNKNOWN
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Lead Sponsor:
Zealand Pharma
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maint...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activity
- Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)
Exclusion
- 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 confound the planned assessments of the trial
- Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. 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) will suffice at the discretion of the Investigator
- Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of 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
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04881825
Start Date
June 16 2021
End Date
April 1 2025
Last Update
November 27 2023
Active Locations (19)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
Mayo Clinic College of Medicin
Rochester, Minnesota, United States, 55905
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
4
Vanderbilt University Medical Center, Nashville
Nashville, Tennessee, United States, 68198-3285