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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005502-25 | EudraCT Number | ||
| U1111-1261-3358 | Other Identifier | WHO |
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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 maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| once-weekly glepaglutide | Experimental | All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glepaglutide | Drug | Glepaglutide will be delivered in a single-use autoinjector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and type of Adverse Events (AEs) | For AEs with onset or worsening following Visit 1 | After 108 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and type of Serious Adverse Events (SAEs) | For AEs with onset or worsening following Visit 1 | After 108 weeks |
| Incidence and type of Adverse Events of Special Interest (AESIs) | For AEs with onset or worsening following Visit 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zealand Pharma | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Mayo Clinic College of Medicin |
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| After 108 weeks |
| Change in body temperature | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in heart rate | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in blood pressure | Seated diastolic and systolic blood pressure | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in body weight | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in hematology - hemoglobin | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in hematology - hematocrit | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in hematology - white blood cell count | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in hematology - platelet count | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - sodium | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - potassium | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - chloride | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - bicarbonate | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - blood urea nitrogen | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - creatinine | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - creatinine clearance | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - glucose | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - calcium | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - phosphorous | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - alkaline phosphatase | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - alanine aminotransferase (ALT) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - aspartate aminotransferase (AST) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - International Normalized Ratio (INR) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - gamma-glutamyl transferase (GGT) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - lactic dehydrogenase | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - conjugated bilirubin | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - total bilirubin | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - total protein | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - albumin | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - amylase | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - uric acid | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in biochemistry - C-reactive protein | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - blood | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - glucose | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - leukocytes | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - pH | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - osmolality | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - protein | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - sodium | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Change in urinalysis - potassium | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Anti-glepaglutide antibodies | Week 0, Week 108 |
| Antibody reactivity to ZP1848 | Week 0, Week 108 |
| Cross-reactivity to glucagon-like peptide-2 (GLP-2) | Week 0, Week 108 |
| Glepaglutide neutralizing antibodies | Week 0, Week 108 |
| Reduction in weekly Parenteral Support (PS) volume | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Reduction of at least 20 percent in weekly PS volume | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Reduction in days on PS greater than or equal to 1 day per week | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Reduction in weekly PS volume of 100 percent (weaned off) | Week 0 in lead-in trial (EASE SBS 1), Week 108 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Vanderbilt University Medical Center, Nashville | Nashville | Tennessee | 68198-3285 | United States |
| Universitair Ziekenhuis Leuven | Leuven | Belgium |
| Rigshospitalet | Copenhagen | Denmark |
| Hôpital Beaujon | Clichy | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | France |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Asklepios Kliniken Hamburg GmbH | Hamburg | Germany |
| Universitätsmedizin Rostock | Rostock | Germany |
| UMC Radboud Nijmegen | Nijmegen | Netherlands |
| Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi | Lodz | Poland |
| Szpital Skawina sp. z o.o. im. Stanley Dudricka | Skawina | Poland |
| St Mark's Hospital | Harrow | United Kingdom |
| UCLH Foundation NHS Trust | London | United Kingdom |
| Norfolk and Norwich University Hospitals | Norwich | United Kingdom |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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