5 completed, 1 unknown, 1 withdrawn. 7 Phase 2, 1 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Unknown 1, Withdrawn 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Unknown 1 |
Follow Hyperammonemia: new trials by email Literature Review of Hyperammonemia trials Research Report on Hyperammonemia
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 |
|---|---|---|---|---|---|---|
| PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia TNP-2092 capsules, Placebo - Hyperammonemia | Phase 1 / Phase 2 | Completed | TenNor Therapeutics (Suzhou) Limited | 36 | 2020-08-27 | 2025-04-25 |
| A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients HepaStem Infusion - Urea Cycle Disorder | Phase 2 | Withdrawn | HLB Cell Co., Ltd. | 2018-07-12 | 2020-11-06 | |
| Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE) ornithine phenylacetate, placebo intravenous infusion - Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy | Phase 2 | Completed | Ocera Therapeutics, Inc. | 231 | 2014-01-07 | 2021-09-16 |
| Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia Carbaglu, Placebo - Propionic Acidemia, Type I and/or Type II, Methylmalonic Acidemia | Phase 2 | Completed | Mendel Tuchman | 35 | 2012-09-01 | 2021-02-15 |
| Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders HPN-100, NaPBA - Urea Cycle Disorders | Phase 2 | Completed | Amgen | 17 | 2010-03-01 | 2024-07-11 |
| N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia N-carbamylglutamate - Inborn Errors of Metabolism | Phase 2 / Phase 3 | Unknown | Mendel Tuchman | 52 | 2008-08-01 | 2020-02-17 |
| Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants Therapeutic Hypothermia, Standard of Care Therapy - Urea Cycle Disorders, Organic Acidemias | Phase 2 | Completed | Uta Lichter-Konecki | 5 | 2007-08-01 | 2015-06-01 |
Urea Cycle Disorders, Inborn (3) · Carbamoyl-Phosphate Synthase I Deficiency Disease (2) · Methylmalonic acidemia (2) · Ornithine Carbamoyltransferase Deficiency Disease (2) · Propionic Acidemia (2) · Argininosuccinic Aciduria (1) · Brain Diseases (1) · Brain Edema (1) · Citrullinemia (1) · Coma (1) · Fibrosis (1) · Hepatic Encephalopathy (1) · Lethargy (1) · Metabolism, Inborn Errors (1)
Pathologic Processes (7) · Pathological Conditions, Signs and Symptoms (7) · Metabolic Diseases (6) · Nutritional and Metabolic Diseases (6) · Brain Diseases, Metabolic (5) · Central Nervous System Diseases (5) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (5) · Genetic Diseases, Inborn (5) · Nervous System Diseases (5) · Amino Acid Metabolism, Inborn Errors (4) · Brain Diseases (4) · Brain Diseases, Metabolic, Inborn (4) · Metabolism, Inborn Errors (4) · Genetic Diseases, X-Linked (2) · Mitochondrial Diseases (2)
carglumic acid (2) · Continuous Renal Replacement Therapy (1) · Cool-Down Exercise (1) · Cryotherapy (1) · Dialysis (1) · Hypothermia, Induced (1) · N-carbamylglutamate (1) · Renal Dialysis (1) · TNP-2092 (1) · glycerol phenylbutyrate (1) · ornithine phenylacetate (1)
Mendel Tuchman (2) · Amgen (1) · HLB Cell Co., Ltd. (1) · Ocera Therapeutics, Inc. (1) · TenNor Therapeutics (Suzhou) Limited (1) · Uta Lichter-Konecki (1)
United States (5) · Australia (1) · Austria (1) · Belgium (1) · Bulgaria (1) · Canada (1) · China (1) · Czechia (1) · Denmark (1) · Estonia (1) · France (1) · Germany (1) · Hungary (1) · Israel (1) · Italy (1)
Mendel Tuchman, MD (2) · Sanghoon Lee, MD. Ph.D (1) · Uta Lichter-Konecki, MD, PhD (1) · Yanhua Ding, MD (1)
PMID 22961727, PMID 24144944, PMID 33006765, PMID 33069881, PMID 34786649, PMID 35238476
R01HD058567 (1)