CLINICAL TRIALS PROFILE FOR LB1148
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Clinical Trials for LB1148
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02317549 ↗ | Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148 | Terminated | Leading BioSciences, Inc | Phase 2 | Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity during physiological shock and ameliorate the subsequent autodigestion leading to MODS and mortality. The purpose of this study in septic shock patients is to determine if enteral administration of LB1148 will increase the number of days alive without cardiovascular, pulmonary or renal replacement therapy through Day 28. |
| NCT02836470 ↗ | A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection | Recruiting | Leading BioSciences, Inc | Phase 2 | The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection. |
| NCT04100447 ↗ | A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection | Completed | Ronald Hurst, MD, FACS | Phase 1 | The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of LB1148 in subjects undergoing elective bowel resection. During abdominal surgery, surgeons handle, manipulate, and often make incisions in the bowel. These actions can create bruising, lesions, and microscopic damage to the bowel, which may allow digestive enzymes to cross the intestinal mucosal barrier potentially resulting in injury both locally and remotely. Leaking digestive enzymes may delay return of normal gastrointestinal (GI) function, lead to a lack of motility in the intestine (ileus), and promote the formation of intestinal scar tissue (adhesions). |
| NCT04390217 ↗ | LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia | Not yet recruiting | Leading BioSciences, Inc | Phase 2 | This is a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19 pneumonia. The primary objective of this study is to determine if enteral administration of LB1148 will effect disease progression in hospitalized patients with moderate to severe COVID-19 via measurement of the proportion of subjects alive and free of respiratory failure at Day 28. |
| NCT05056935 ↗ | Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus | Completed | Newsoara Biopharma Co., Ltd. | Phase 2 | The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection. |
| NCT05470387 ↗ | A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection | Recruiting | Palisade Bio | Phase 3 | The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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