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| ID | Type | Description | Link |
|---|---|---|---|
| DOLPHINS-2 | Other Identifier | Hanmi Pharm. Co., Ltd. |
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This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15912 Active | Drug | Randomized, double-blind, placebo-controlled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | after multiple subcutaneous (SC) doses | for 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wooyoung Amy Hong | Contact | +82 2 410 9238 | wooyoung.hong@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States | |
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| Placebo | Drug | Randomized, double-blind, placebo-controlled |
|
| The Cleveland Clinic Foundation |
| Recruiting |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| UZ Leuven | Recruiting | Leuven | Vlaams Brabant | 3000 | Belgium |
| Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure | Recruiting | Copenhagen | 2100 | Denmark |
| Hopital Beaujon | Recruiting | Clichy | Clichy | 92110 | France |
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Bordeaux | 33000 | France |
| Les Hospices Civils de Lyon | Recruiting | Lyon | 69002 | France |
| Centre Hospitalier Universitaire de Nice | Recruiting | Nice | 06300 | France |
| Asklepios Klinik St. Georg | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20099 | Germany |
| Universitätsklinikum Tübingen | Recruiting | Tübingen | Tübingen | 72076 | Germany |
| Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi | Recruiting | Lodz | Łódź Voivodeship | 90-531 | Poland |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Salford Royal Hospital | Recruiting | Salford | Greater Manchester | M6 8HD | United Kingdom |
| Central Middlesex Hospital | Recruiting | London | NW10 7NS | 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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