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Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMT-101 (Dose A) | Active Comparator | Dose A: AMT-101 Tablet |
|
| AMT-101 (Dose B) | Active Comparator | Dose B: AMT-101 Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-101 (oral)-Dose A | Drug | AMT-101 is an orally administered biologic therapeutic, taken once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool Frequency Response | 12 weeks | |
| Histologic Healing | based upon the Geboes scoring system and PDAI | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Response | based upon the Geboes scoring system and PDAI | 12 weeks |
| Change in Endoscopic Score | 12 weeks | |
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Inclusion Criteria:
• Chronic or recurrent pouchitis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Clinical Research Institute | Bristol | Connecticut | 06010 | United States | ||
| University of Chicago Medical Center |
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| AMT-101 (oral)-Dose B | Drug | AMT-101 is an orally administered biologic therapeutic, taken once daily. |
|
| Change in Stool Frequency |
| 12 weeks |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Gastrointestinal Associates - Jackson | Flowood | Mississippi | 39232 | United States |
| University of North Carolina GI | Chapel Hill | North Carolina | 27514 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Gastrointestinal Asssociates- GIA Clinical Trials, LLC | Knoxville | Tennessee | 37909 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Washington Gastroenterology, Tacoma | Tacoma | Washington | 98405 | United States |
| UZ Leuven - University Hospital Gasthuisberg | Leuven | Belgium |
| Groupe santé CHC / Clinique du MontLégia, Liege | Liège | Belgium |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| CHU de Rennes - Hopital de Pontchaillou | Rennes | France |
| CHU Saint Etienne - Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| CHU de Toulouse - Hôpital Rangueil | Toulouse | 31059 | France |
| CHRU Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Praxis fur Gastroenterologie am Bayerischen Platz | Berlin | D-10825 | Germany |
| Klinik für Innere Medizin KIM IV | Jena | Germany |
| UKSH Universitätsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| University Hospital Tübingen | Tübingen | Germany |
| Semmelweis Egyetem I. sz Belgyogyaszati Klinika | Budapest | 1083 | Hungary |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar | Szeged | Hungary |
| ETZ - Elisabeth | Tilburg | Netherlands |
| Hospital Universitario y Politecnico La Fe de Valencia | Valencia | 46026 | Spain |
| Clarunis Bauchzentrum | Basel | Switzerland |
| University Hospital of Zürich | Zurich | Switzerland |
| MAC Clinical Research - Blackpool | Blackpool | Lancashire | FY2 0JH | United Kingdom |
| MAC Clinical Research - Liverpool | Prescot | Liverpool | L34 1BH | United Kingdom |
| MAC Clinical Research - Cannock | Cannock | South Staffordshire | WS11 0BN | United Kingdom |
| MAC Clinical Research - Leeds | Leeds | West Yorkshire | LS10 1DU | United Kingdom |
| MAC Clinical Research - Manchester | Manchester | M13 9NQ | United Kingdom |
| ID | Term |
|---|---|
| D019449 | Pouchitis |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |
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