9 completed, 3 active not recruiting, 1 recruiting, 1 unknown. 7 Phase 2, 6 Phase 3, 4 Phase 4, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 4, Active not recruiting 2, Unknown 1 |
| Phase 3 | 6 | Active not recruiting 3, Completed 3 |
| Phase 4 | 4 | Completed 3, Withdrawn 1 |
| Phase 1 | 2 | Completed 1, Recruiting 1 |
Follow idursulfase: new trials by email Literature Review of idursulfase trials Research Report on idursulfase
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[MPS] II) ELAPRASE, Rituximab, Methotrexate - Mucopolysaccharidosis (MPS), Hunter Syndrome | Phase 4 | Withdrawn | Takeda | 2023-02-28 | 2025-12-09 | |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 Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II) tividenofusp alfa, idursulfase - Mucopolysaccharidosis II | Phase 2 / Phase 3 | Active not recruiting | Denali Therapeutics Inc. | 65 | 2022-07-21 | 2026-09-09 |
| 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 |
| A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) JR-141, Idursulfase, JR-141 or Idursulfase - Mucopolysaccharidosis II | Phase 3 | Active not recruiting | JCR Pharmaceuticals Co., Ltd. | 86 | 2022-02-14 | 2026-10-02 |
| PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders) Aldurazyme (laronidase) - MPS I, MPS II | Phase 1 | Recruiting | University of California, San Francisco | 10 | 2021-07-01 | 2026-03-17 |
| Study of Idursulfase-beta (GC1111) in Hunter Syndrome idursulfase beta, idursulfase - Mucopolysaccharidosis II | Phase 2 | Unknown | Green Cross Corporation | 20 | 2016-12-01 | 2016-01-26 |
| 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 |
| A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723 Idursulfase, GSK2788723 - Mucopolysaccharidosis II | Completed | GlaxoSmithKline | 10 | 2012-04-09 | 2017-09-25 | |
| 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 |
| An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Idursulfase - Hunter Syndrome | Completed | Shire | 26 | 2008-10-14 | 2021-06-08 | |
| Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy Idursulfase - Hunter Syndrome, Mucopolysaccharidosis II | Phase 4 | Completed | Shire | 28 | 2007-12-31 | 2021-06-08 |
| 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 (14) · Sudden Infant Death (7) · Lysosomal Storage Diseases (4) · Gaucher Disease (1) · Mucopolysaccharidoses (1) · Mucopolysaccharidosis IV (1) · Mucopolysaccharidosis VI (1) · Mucopolysaccharidosis VII (1) · Wolman Disease (1)
Shire (6) · Takeda (4) · Denali Therapeutics Inc. (1) · GlaxoSmithKline (1) · Green Cross Corporation (1) · JCR Pharmaceuticals Co., Ltd. (1) · University of California, San Francisco (1)
United States (10) · United Kingdom (7) · Brazil (6) · Canada (5) · France (5) · Germany (5) · Spain (4) · Italy (3) · Argentina (2) · Poland (2) · Sweden (2) · Turkey (Türkiye) (2) · Australia (1) · Belgium (1) · Colombia (1)
Jose Alcantara Rodriguez, PharmD (1) · Tippi MacKenzie, MD (1)
PMID 15324318, PMID 19948615, PMID 21150784, PMID 21637107, PMID 22929184, PMID 23510062, PMID 23837440, PMID 25902842, PMID 28243577, PMID 28374935, PMID 28657663, PMID 30337566, PMID 32102934, PMID 33874971, PMID 35588317, PMID 35961250, PMID 37915038, PMID 37955580, PMID 39891377, PMID 9918480
2014 (2), 2004 (1), 2023 (1)