CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Idursulfase-IT +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01506141
NCT01506141Phase 2Completed
CompareCT.gov

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

Takeda·interventional·Posted Jan 9, 2012·Updated Aug 6, 2025

In Brief

A Phase 2 clinical trial evaluating Idursulfase-IT and Elaprase for Hunter Syndrome. Completed, enrolled 15 participants across 9 sites in 3 countries.

Detailed Summary

This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV) Elaprase enzyme replacement therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome
CountriesCanada, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2012
Enrollment StartAug 1, 2010
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 13.7 yearsPosted 14.5 years ago

Interventions

Idursulfase-ITdrug

Idursulfase-IT once monthly via IDDD.

Elaprasedrug

Weekly IV infusions of commercially available Elaprase.