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The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraglutide subcutaneous (SC) injections, once weekly | Experimental | Peptide analogue of Glucagon-like Peptide 2 (GLP-2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraglutide | Drug | Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | System organ class, frequency and severity | From baseline to week 208 |
| Clinical chemistry | Clinical Chemistry panel of analytes will be examined for clinically significant changes. | From baseline to week 208 |
| Hematology | Hematology panel of analytes will be examined for clinically significant changes. | From baseline to week 208 |
| Hemostasis | Hemostasis INR will be examined for clinically significant changes. | From baseline to week 104 |
| Urinalysis | Urinanalysis panel of analytes will be examined for clinically significant changes. | From baseline to week 208 |
| Occurrence of clinically relevant changes in vital signs |
| From baseline to week 208 |
| Occurrence of clinically relevant changes in electrocardiogram | ECG; intervals and rhythm | From baseline to week 208 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PS volume | From baseline to week 208 | |
| Change from baseline in PS frequency | Change in PS days/week from baseline to week 104 | From baseline to week 208 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Masior | VectivBio AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Gastroenterology Group of Naples |
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| Clinically significant changes in PS total energy | Units: kcal | From baseline to week 208 |
| Change from baseline in PS infusion time | From baseline to week 208 |
| Percentage of subjects reaching enteral autonomy | From baseline to week 104 |
| Change from baseline in body weight | Units: kg | From baseline to week 104 |
| Change from baseline on the Patient Global Impression of Severity (PGIS) | From baseline to week 104 |
| Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) | From baseline to week 208 |
| Change from baseline on the Patient Global Impression of Change (PGIC) | From baseline to week 208 |
| Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS) | From baseline to week 208 |
| Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) | From baseline to week 208 |
| Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI) | From baseline to week 208 |
| Change from baseline on the Short Form (36) Health Survey (SF-36) | From baseline to week 208 |
| Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L) | From baseline to week 208 |
| Naples |
| Florida |
| 34102 |
| United States |
| Northwestern University - Chicago | Chicago | Illinois | 60611 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University Hospital Fundacion Favaloro | Buenos Aires | C1093AAS | Argentina |
| University Hospital Brussels | Brussels | B-1090 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| University Hospital Brno | Brno | 62500 | Czechia |
| University Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Hospital Novy Jicin | Nový Jičín | 741 01 | Czechia |
| University Hospital Plzen | Pilsen | 30460 | Czechia |
| University Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| General University Hospital in Prague | Prague | 12800 | Czechia |
| Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases | Copenhagen | 2100 | Denmark |
| Beaujon Hospital | Clichy | 92110 | France |
| South Lyon Hospital Center | Lyon | 69495 | France |
| Nantes University Hospital Center - Hotel Dieu Hospital | Nantes | 44093 | France |
| Nice University Hospital Center - Archet 1 Hospital | Nice | 06200 | France |
| Hôpital Haut-Lévèque | Pessac | 33604 | France |
| Brabois Adults Hospital | Vandœuvre-lès-Nancy | 54500 | France |
| Charite - University Hospital Berlin | Berlin | 10117 | Germany |
| University Hospital Bonn | Bonn | 53127 | Germany |
| Asklepios Clinic St. Georg | Hamburg | 20099 | Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital Muenster | Münster | 48149 | Germany |
| Szent Imre University Teaching Hospital, Department of Gastroenterology | Budapest | 1115 | Hungary |
| Central Hospital of Northern Pest - Military Hospital | Budapest | H-1062 | Hungary |
| Semmelweis University | Budapest | H-1062 | Hungary |
| University of Szeged | Szeged | 6725 | Hungary |
| Rambam Health Care Campus, Institute of Gastroenterology | Haifa | 31096 | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 5262000 | Israel |
| Polyclinic S. Orsola-Malpighi | Bologna | 40138 | Italy |
| University Polyclinic Foundation "Agostino Gemelli" - IRCCS | Rome | 00168 | Italy |
| City of Health and Science of Turin | Turin | 10126 | Italy |
| Yokohama City University Medical Center | Kanagawa | 232-0024 | Japan |
| Yokohama Municipal Citizen's Hospital | Kanagawa | 232-0024 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Tohoku University Hospital | Sendai | 980-0872 | Japan |
| JCHO Tokyo Yamate Medical Center | Tokyo | 169-0073 | Japan |
| More og Romsdal Hospital Trust - Alesund Hospital | Ålesund | 6017 | Norway |
| Stadmedica, Non-Public Healthcare Facility | Bydgoszcz | 85-391 | Poland |
| COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults | Gdansk | 80-152 | Poland |
| M. Pirogow Provincial Specialized Hospital | Lodz | 90-531 | Poland |
| Gastromed Poland Sp. z o.o. | Lublin | 20-582 | Poland |
| Stanley Dudrick Multispecialty Hospital | Skawina | 32-050 | Poland |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 063351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| University General Hospital Gregorio Maranon | Madrid | 28007 | Spain |
| University Hospital 12 de Octubre | Madrid | 28041 | Spain |
| University Hospital Virgen del Rocio (HUVR) | Seville | 41013 | Spain |
| Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre | Gothenburg | 413 45 | Sweden |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| St Mark's Hospital | Harrow | HA1 3UJ | United Kingdom |
| Royal London Hospital | London | E1 1BB | United Kingdom |
| University College Hospital | London | NW1 2BU | United Kingdom |
| Northern Care Alliance NHS Foundation Trust | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D000090124 | Intestinal Failure |
| 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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| ID | Term |
|---|---|
| C000710330 | apraglutide |
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