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Idursulfase-IT

DRUG5 trials

Sponsors

Takeda, Shire

Conditions

Hunter Syndrome

Phase 1

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
CompletedNCT01506141
TakedaHunter Syndrome
Start: 2010-08-01End: 2024-04-30Updated: 2025-08-06

Phase 2

Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
CompletedNCT02055118
ShireHunter Syndrome
Start: 2014-03-24End: 2017-09-28Updated: 2021-06-11
Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094
CompletedNCT02412787
ShireHunter Syndrome
Start: 2015-04-14End: 2024-04-18Updated: 2025-06-19
Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment
Active, not recruitingNCT06031259
TakedaHunter Syndrome
Start: 2024-03-05End: 2029-01-01Updated: 2025-11-06

Unknown Phase

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
NCT05795361
TakedaHunter Syndrome
Updated: 2025-04-22

Related Papers

Intrathecal idursulfase‐IT in children younger than 3 years with neuronopathic mucopolysaccharidosis II in a single‐arm, open‐label, phase 2/3 substudy and extension
UNC Libraries2026-03-17
Intrathecal idursulfase‐ <scp>IT</scp> in children younger than 3 years with neuronopathic mucopolysaccharidosis <scp>II</scp> in a single‐arm, open‐label, phase 2/3 substudy and extension
JIMD Reports2026-02-22
Evaluation of early treatment with intravenous idursulfase and intrathecal idursulfase‐ <scp>IT</scp> on cognitive function in siblings with neuronopathic mucopolysaccharidosis <scp>II</scp>
Journal of Inherited Metabolic Disease2024-09-092 citations
Clinical investigator perspectives on patient outcomes in children with neuronopathic mucopolysaccharidosis II during intrathecal idursulfase-IT treatment.
2024-04-12
Neurodevelopmental status and adaptive behavior of pediatric patients with mucopolysaccharidosis II: a longitudinal observational study
Orphanet Journal of Rare Diseases2023-11-168 citations
A post hoc analysis of Projected Retained Ability Scores (PRAS) for the longitudinal assessment of cognitive functioning in patients with neuronopathic mucopolysaccharidosis II receiving intrathecal idursulfase-IT.
2023-11-021 citations
Cognitive and adaptive behaviors associated with disease severity and genotype in patients with mucopolysaccharidosis II.
2023-07-132 citations
Intrathecal idursulfase-IT in patients with neuronopathic mucopolysaccharidosis II: Results from a phase 2/3 randomized study
Molecular Genetics and Metabolism2022-08-0245 citations
Long-term open-label extension study of the safety and efficacy of intrathecal idursulfase-IT in patients with neuronopathic mucopolysaccharidosis II
Molecular Genetics and Metabolism2022-08-0223 citations
Long-term open-label phase I/II extension study of intrathecal idursulfase-IT in the treatment of neuronopathic mucopolysaccharidosis II.
2022-05-208 citations
Analysis of cognitive ability and adaptive behavior assessment tools used in an observational study of patients with mucopolysaccharidosis II.
2021-12-048 citations