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The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glepaglutide SC injections twice weekly | Experimental | Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm. |
|
| Glepaglutide SC injections once weekly and placebo once weekly | Experimental | Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly. In this long term safety study, there is no placebo arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glepaglutide | Drug | Glucagon-Like Peptide-2 (GLP-2) analog |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse Events | Incidence and type of Adverse Events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Serious Adverse Events | Incidence and type of Serious Adverse Events | 2 years |
| Safety - Adverse Events of Special Interest | Incidence and type of Adverse Events of Special Interest |
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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 | ||
| University of Chicago Children's Hospital |
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|
| 2 years |
| Safety - Changes in blood pressure from baseline | Changes in systolic and diastolic blood pressure will be reported | 2 years |
| Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) | Number of patients with clinically significant changes in ECG will be reported | 2 years |
| Immunogenicity - Occurrence of anti-drug antibodies | Occurrence of antibodies against glepaglutide | 2 years |
| Change in weekly Parenteral Support (PS) volume | Change in weekly PS volume from baseline | 2 years |
| Number of patients with 20 percent reduction in PS volume | Achieving at least 20 percent reduction in weekly PS volume from baseline | 2 years |
| Days off PS | Achieving 1 or more days per week off PS | 2 years |
| Weaned off PS | Reduction in weekly PS volume of 100 percent (weaned off) | 2 years |
| Changes in fluid composite effect | Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline | 2 years |
| Energy content (lipids) | Change in lipids content (in kcal/L or kjoule/L) of PS from baseline | 2 years |
| Energy content (glucose) | Change in glucose content (in kcal/L or kjoule/L) of PS from baseline | 2 years |
| Energy content (amino acids) | Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline | 2 years |
| Days on PS | Change in number of days on PS per week from baseline | 2 years |
| Number of patients with 40 percent change in PS volume per week | Achieving 40 percent in PS volume from baseline | 2 years |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Mayo Clinic College of Medicine | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3285 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center, Nashville | Nashville | Tennessee | 68198-3285 | United States |
| UZ Leuven | Leuven | Belgium |
| The Royal Alexandra Hospital | Edmonton | Canada |
| Western University | London | N6A 4V2 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Canada |
| 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 - Med. Klinik I | 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 |
| Solumed | Poznan | 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 |
| University of East Anglia | Norwich | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | 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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