6 completed. 6 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 3 | Completed 3 |
Follow Sudden Infant Death: new trials by email Literature Review of Sudden Infant Death trials Research Report on Sudden Infant Death
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 Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) Hunterase - MPS II, Hunter Syndrome (MPS II) | Phase 3 | Completed | GC Biopharma Corp | 30 | 2018-05-23 | 2026-01-15 |
| A Study of GC1111 in Hunter Syndrom Patients GC1111, Comparator - Hunter Syndrome | Phase 3 | Completed | Green Cross Corporation | 32 | 2017-03-09 | 2024-04-16 |
| Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment idursulfase-IT, No IT treatment - Hunter Syndrome | Phase 2 / Phase 3 | Completed | Shire | 58 | 2014-03-24 | 2021-06-11 |
| Influence of Pacifiers on Breastfeeding Duration offer a pacifier - Sudden Infant Death | Phase 3 | Completed | Fundacion para la Salud Materno Infantil | 1021 | 2006-03-01 | 2008-09-19 |
| Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase Idursulfase - Hunter Syndrome, Mucopolysaccharidosis II (MPS II) | Phase 2 / Phase 3 | Completed | Shire | 94 | 2004-09-13 | 2021-06-10 |
| Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II) Iduronate-2-sulfatase enzyme replacement therapy, iduronate-2-sulfatase enzyme replacement therapy, Placebo - Mucopolysaccharidosis II | Phase 2 / Phase 3 | Completed | Shire | 96 | 2003-09-18 | 2021-06-10 |
Mucopolysaccharidosis II (5) · Lysosomal Storage Diseases (2) · Breast Feeding (1)
Death (6) · Death, Sudden (6) · Infant Death (6) · Pathologic Processes (6) · Pathological Conditions, Signs and Symptoms (6) · Carbohydrate Metabolism, Inborn Errors (5) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (5) · Connective Tissue Diseases (5) · Genetic Diseases, Inborn (5) · Genetic Diseases, X-Linked (5) · Heredodegenerative Disorders, Nervous System (5) · Intellectual Disability (5) · Metabolic Diseases (5) · Metabolism, Inborn Errors (5) · Mucinoses (5)
idursulfase (2) · Iduronate Sulfatase (1)
Shire (3) · Fundacion para la Salud Materno Infantil (1) · GC Biopharma Corp (1) · Green Cross Corporation (1)
United Kingdom (3) · United States (3) · Brazil (2) · Canada (2) · France (2) · Germany (2) · South Korea (2) · Spain (2) · Argentina (1) · Australia (1) · Italy (1) · Mexico (1) · Romania (1) · Sweden (1)
Alejandro Jenik, M.D. (1) · DongKyu Jin, M.D., Ph.D. (1)
PMID 21150784, PMID 22929184, PMID 23837440, PMID 33874971, PMID 35961250, PMID 36027721, PMID 37915038, PMID 42421116
2004 (1)