Short Bowel Syndrome
Conditions
Interventions
All patients will undergo the following interventions:
- ECG
- Vital signs, including weight
- Physical examination (full physical examination at Visit 1
SBS
symptom-driven at all other visits)
- Colonoscopy or CT/MRI (In case a remnant colon is not connected to the
passage of foods and thereby dormant, a CT-scan or MRI (if standard of care at
site)
Sponsors
Zealand Pharma A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The patient must meet both of the following inclusion criteria: 1. Signed informed consent 2. Completed the full treatment period of the extension trial EASE SBS 2
Exclusion criteria
Exclusion criteria: The patient must be excluded from this trial if any of the following criteria are met: 1. 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. 2. Not having a colonoscopy performed at EOT 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 EOT 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. 3. 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. 4. Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. 5. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 6. An employee of the sponsor or Investigator or otherwise dependent on them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For all patients, changes from baseline are relative to the baseline assessment in the lead-in trial, EASE SBS 1, if not otherwise specified. Safety Endpoints: Primary Endpoint: Incidence and type of adverse events (AEs), with onset or worsening following Visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Secondary Endpoints: • Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) (with onset or worsening following Visit 1) • Changes from baseline in: - Vital signs - Electrocardiogram • Changes from baseline in: - Hematology - Biochemistry - Urinalysis • Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies) Efficacy Endpoints: The secondary efficacy endpoints are: • Reduction in weekly PS volume (prescribed) from baseline • Reduction of at least 20% in weekly PS volume (prescribed) from baseline • Reduction in days on PS >= 1 day/week from baseline • Reduction in weekly PS volume of 100% (weaned off) | — |
Countries
Netherlands
Outcome results
None listed