7 completed, 2 terminated. 7 Phase 2, 1 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Terminated 2 |
| Not applicable | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Metabolism of Ornithine Phenylacetate phenylacetate salt of ornithine - Healthy | Not applicable | Completed | Texas A&M University | 20 | 2015-02-03 | 2025-09-30 |
| Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury Ornithine Phenylacetate - Acute Liver Failure, Acute Liver Injury | Phase 2 | Completed | William Lee | 47 | 2012-06-01 | 2018-10-30 |
| AST-120 Used to Treat Mild Hepatic Encephalopathy AST-120 - Mild Hepatic Encephalopathy | Phase 2 | Completed | Ocera Therapeutics | 148 | 2009-03-01 | 2014-06-18 |
| Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI AST-120, Celphere CP-305 - Gastroesophageal Reflux Disease (GERD) | Phase 2 | Terminated | Ocera Therapeutics | 4 | 2007-10-01 | 2014-06-18 |
| Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy AST-120, lactulose - Hepatic Encephalopathy | Phase 2 | Completed | Ocera Therapeutics | 40 | 2007-09-01 | 2014-05-30 |
| Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome AST-120, Celphere® CP-305 - Irritable Bowel Syndrome | Phase 2 | Completed | Ocera Therapeutics | 117 | 2007-08-01 | 2014-06-18 |
| Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis AST-120 - Pouchitis | Phase 2 | Terminated | Ocera Therapeutics | 2 | 2007-03-01 | 2014-06-18 |
| Safety and Efficacy of AST-120 in the Treatment of Pouchitis AST-120 - Pouchitis | Phase 2 | Completed | Ocera Therapeutics | 19 | 2007-02-01 | 2014-06-18 |
| Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas AST-120 - Inflammatory Bowel Disease, Intestinal Fistula | Phase 3 | Completed | Ocera Therapeutics | 191 | 2006-03-01 | 2014-05-30 |
Hepatic Encephalopathy (2) · Liver Diseases (2) · Pouchitis (2) · Brain Diseases (1) · Chemical and Drug Induced Liver Injury (1) · Cognitive Dysfunction (1) · Colitis, Ulcerative (1) · Crohn Disease (1) · Fibrosis (1) · Fistula (1) · Gastroesophageal Reflux (1) · Hepatitis B (1) · Hepatitis, Autoimmune (1) · Inflammatory Bowel Diseases (1) · Intestinal Fistula (1)
AST 120 (7) · Lactulose (1) · ornithine phenylacetate (1)
United States (9) · Belgium (2) · Austria (1) · Canada (1) · Czechia (1) · France (1) · Germany (1) · Hungary (1) · Israel (1) · Netherlands (1) · Poland (1) · United Kingdom (1)
Bo Shen, MD (1) · Darrell S. Pardi, MD (1) · Jan Tack, MD (1) · Jeff Bornstein, MD (1) · Laurent Fischer, MD (1) · Marielle Engelen, PhD (1) · Paul Pockros, MD (1) · Ronnie Fass, MD (1) · William M Lee, MD (1)
PMID 21883322, PMID 37183883, PMID 39423760, PMID 42149813
U01DK058369 (1)