Short Bowel Syndrome (SBS)
Conditions
Keywords
Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Postoperative Complications, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Short Bowel Syndrome
Brief summary
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Detailed description
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Interventions
DRUGGlepaglutide 10 mg
Administered twice weekly by subcutaneous injection for a maximum of 24 months
Sponsors
Zealand Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has provided signed informed consent and agrees to comply with protocol requirements. * Is being 1. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or 2. Actively treated in the EASE SBS 3 trial.
Exclusion criteria
* Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial. * Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed. * Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial. * Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.) * If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception. * Has a known or suspected hypersensitivity to glepaglutide or related products. * Has committed to an institution by virtue of an order issued by the judicial or administrative authorities. * Is an employee of the sponsor or investigator or otherwise dependent on them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (TEAEs) | From baseline to the safety follow-up visit (A maximum of 25 months) |
Secondary
| Measure | Time frame |
|---|---|
| Change in prescribed weekly parenteral support (PS) volume | From baseline to Month 24 (End of Trial) |
Countries
Belgium, Canada, France, Germany, Poland, United Kingdom, United States
Outcome results
None listed