Elaprase

DRUG5 trials

Sponsors

Takeda, Shire

Conditions

Hunter SyndromeMucopolysaccharidosis (MPS)

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 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

Phase 4

A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India

CompletedNCT05058391

TakedaHunter Syndrome

Start: 2022-04-21End: 2024-04-18Updated: 2025-01-23

A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)

WithdrawnNCT05494593

TakedaHunter Syndrome, Mucopolysaccharidosis (MPS)

Start: 2023-02-28End: 2025-08-29Updated: 2025-12-09

Related Papers

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

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

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