Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zealand Pharma
The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent;
Age of 18 to 90 years;
A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
Stable PS need of ≥3 days per week;
No restorative surgery planned during the trial period;
Having a stoma or colon in continuity.
You may not be if
More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
