18 completed, 3 active not recruiting, 2 terminated, 1 available. 8 Phase 2, 7 Phase 3, 4 Phase 4, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 6, Active not recruiting 2 |
| Phase 3 | 7 | Completed 6, Active not recruiting 1 |
| Phase 4 | 4 | Completed 3, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Active not recruiting 1 |
Follow Hunter Syndrome: new trials by email Literature Review of Hunter Syndrome trials Research Report on Hunter Syndrome
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 |
|---|---|---|---|---|---|---|
| Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment Idursulfase-IT, Elaprase - Hunter Syndrome | Phase 2 / Phase 3 | Active not recruiting | Takeda | 6 | 2024-03-05 | 2025-11-06 |
| A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) ELAPRASE, Rituximab, Methotrexate - Mucopolysaccharidosis (MPS), Hunter Syndrome | Phase 4 | Withdrawn | Takeda | 2023-02-28 | 2025-12-09 | |
| A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ GC1123 - Mucopolysaccharidosis II, Hunter Syndrome | Phase 1 | Active not recruiting | GC Biopharma Corp | 12 | 2022-09-20 | 2024-10-15 |
| A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India Elaprase - Hunter Syndrome | Phase 4 | Completed | Takeda | 5 | 2022-04-21 | 2025-01-23 |
| MPS II Immunophenotyping MPS II, Mucopolysaccharidosis II | Terminated | Duke University | 6 | 2022-04-01 | 2024-09-19 | |
| Biomarkers for Hunter Syndrome Hunter Syndrome, Mucopolysaccharidosis II | Terminated | CENTOGENE GmbH Rostock | 11 | 2018-08-20 | 2023-02-10 | |
| 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 |
| Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701) Hunter Syndrome | Completed | Shire | 5 | 2018-01-19 | 2023-09-15 | |
| 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 |
| Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age Elaprase for intravenous (IV) infusion - Hunter Syndrome | Phase 4 | Completed | Shire | 21 | 2015-10-28 | 2026-04-02 |
| Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094 Idursulfase-IT, Elaprase - Hunter Syndrome | Phase 2 / Phase 3 | Completed | Shire | 56 | 2015-04-14 | 2025-06-19 |
| MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis Stem Cell Transplantation, IMD Preparative Regimen, Osteopetrosis Only Preparative Regimen - Mucopolysaccharidosis Disorders, Hurler Syndrome | Phase 2 | Active not recruiting | Masonic Cancer Center, University of Minnesota | 149 | 2014-07-10 | 2026-01-07 |
| 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 |
| The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients Hunter Syndrome | Unknown | Green Cross Corporation | 34 | 2014-01-01 | 2014-06-20 | |
| Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II) Mucopolysaccharidosis (MPS), Hunter Syndrome | Completed | Shire | 100 | 2013-01-18 | 2021-03-17 | |
| Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome No treatment - Hunter Syndrome | Completed | Shire | 10 | 2012-11-12 | 2021-06-09 | |
| Safety and Efficacy of Hunterase Hunterase - Hunter Syndrome | Phase 3 | Completed | Green Cross Corporation | 6 | 2012-07-01 | 2014-07-08 |
| An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment Idursulfase-IT, Elaprase - Hunter Syndrome | Phase 1 / Phase 2 | Completed | Takeda | 15 | 2010-08-01 | 2025-08-06 |
| Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Campath-1H, Cyclophosphamide, Busulfan - Mucopolysaccharidosis, Hurler Syndrome | Phase 2 | Completed | Masonic Cancer Center, University of Minnesota | 46 | 2009-12-01 | 2018-02-05 |
| A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase® Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg) - Hunter Syndrome | Phase 1 / Phase 2 | Completed | Shire | 16 | 2009-11-18 | 2021-06-28 |
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Mucopolysaccharidosis II (26) · Sudden Infant Death (10) · Lysosomal Storage Diseases (6) · Mucopolysaccharidoses (4) · Aspartylglucosaminuria (2) · Fucosidosis (2) · Leukodystrophy, Globoid Cell (2) · Leukodystrophy, Metachromatic (2) · Mucopolysaccharidosis I (2) · Mucopolysaccharidosis VI (2) · Mucopolysaccharidosis VII (2) · Peroxisomal Disorders (2) · Sphingolipidoses (2) · alpha-Mannosidosis (2) · Adrenoleukodystrophy (1)
Carbohydrate Metabolism, Inborn Errors (26) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (26) · Connective Tissue Diseases (26) · Genetic Diseases, Inborn (26) · Genetic Diseases, X-Linked (26) · Heredodegenerative Disorders, Nervous System (26) · Intellectual Disability (26) · Metabolic Diseases (26) · Metabolism, Inborn Errors (26) · Mucinoses (26) · Nervous System Diseases (26) · Neurobehavioral Manifestations (26) · Neurologic Manifestations (26) · Nutritional and Metabolic Diseases (26) · Skin and Connective Tissue Diseases (26)
idursulfase (9) · Stem Cell Transplantation (2) · Alemtuzumab (1) · Busulfan (1) · Cyclophosphamide (1) · Cyclosporine (1) · Iduronate Sulfatase (1) · Immunoglobulins, Intravenous (1) · Methotrexate (1) · Mycophenolic Acid (1) · Regimen B (1) · Rituximab (1)
Shire (12) · Takeda (5) · Green Cross Corporation (3) · GC Biopharma Corp (2) · Masonic Cancer Center, University of Minnesota (2) · CENTOGENE GmbH Rostock (1) · Duke University (1)
United States (16) · United Kingdom (10) · Mexico (6) · Canada (5) · South Korea (5) · Spain (5) · France (4) · Australia (3) · Brazil (3) · Germany (2) · Argentina (1) · Dominican Republic (1) · India (1) · Italy (1) · Malaysia (1)
Dong-Kyu Jin (2) · Arndt Rolfs, Prof. Dr. (1) · DongKyu Jin, M.D., Ph.D. (1) · Paul Orchard, M.D. (1) · Paul Orchard, MD (1) · Priya Kishnani, MD (1)
PMID 35961250, PMID 37915038, PMID 21150784, PMID 22929184, PMID 25902842, PMID 28243577, PMID 35588317, PMID 36027721, PMID 37974184, PMID 40598289, PMID 42421116
2014 (2), 2004 (1), 2023 (1)