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An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment

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Trial Profile

An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Aug 2025

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At a glance

  • Drugs Idursulfase (Primary) ; Idursulfase
  • Indications Mucopolysaccharidosis II
  • Focus Adverse reactions
  • Sponsors Shire; Takeda

Most Recent Events

  • 06 Aug 2025 Protocol has been amended. Interventional Study Model changed from Single Group Assignment to Parallel Assignment. Number of arms changed from 1 to 3, Experimental: Idursulfase-IT 10 mg and Experimental: Idursulfase-IT 30 mg has been added to study protocol.
  • 06 Aug 2025 Interventional Study Model changed from Single Group Assignment to Parallel Assignment. Number of arms changed from 1 to 3, Experimental: Idursulfase-IT 10 mg and Experimental: Idursulfase-IT 30 mg has been added to study protocol.
  • 06 May 2024 Status changed from active, no longer recruiting to completed.

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