3 completed, 1 active not recruiting, 1 unknown. 5 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Unknown 1 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency ECUR-506 - Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease | Phase 3 | Active not recruiting | iECURE, Inc. | 20 | 2024-04-08 | 2026-09-30 |
| Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs) HPN-100 - Urea Cycle Disorders | Phase 3 | Completed | Amgen | 23 | 2011-07-01 | 2024-07-11 |
| Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD) HPN-100 - Urea Cycle Disorders | Phase 3 | Completed | Amgen | 60 | 2009-11-01 | 2024-07-10 |
| Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders HPN-100, Buphenyl (NaPBA) - Urea Cycle Disorders | Phase 3 | Completed | Amgen | 46 | 2009-10-01 | 2024-07-09 |
| 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 |
Urea Cycle Disorders, Inborn (4) · Metabolism, Inborn Errors (2) · Amino Acid Metabolism, Inborn Errors (1) · Brain Diseases (1) · Brain Diseases, Metabolic (1) · Brain Diseases, Metabolic, Inborn (1) · Central Nervous System Diseases (1) · Genetic Diseases, Inborn (1) · Genetic Diseases, X-Linked (1) · Liver Diseases (1) · Metabolic Diseases (1) · Nervous System Diseases (1) · Ornithine Carbamoyltransferase Deficiency Disease (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (5) · Nutritional and Metabolic Diseases (5) · Pathologic Processes (5) · Pathological Conditions, Signs and Symptoms (5) · Genetic Diseases, Inborn (4) · Metabolic Diseases (4) · Amino Acid Metabolism, Inborn Errors (3) · Brain Diseases (3) · Brain Diseases, Metabolic (3) · Brain Diseases, Metabolic, Inborn (3) · Central Nervous System Diseases (3) · Metabolism, Inborn Errors (3) · Nervous System Diseases (3) · Digestive System Diseases (1)
glycerol phenylbutyrate (3) · 4-phenylbutyric acid (1) · N-carbamylglutamate (1) · carglumic acid (1)
Amgen (3) · Mendel Tuchman (1) · iECURE, Inc. (1)
United States (5) · Canada (2) · Australia (1) · Spain (1) · United Kingdom (1)
George Diaz, M.D., Ph.D (1) · Mendel Tuchman, MD (1)
PMID 24144944, PMID 22961727, PMID 23324524
R01HD058567 (1)