At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
idursulfase-IT +1 morebiological
Likely dose
idursulfase-IT 10mgfrom 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.
A Controlled, Randomized, Two-arm, Open-label, Assessor-blinded, Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
In Brief
A Phase 3 clinical trial evaluating idursulfase-IT and No IT treatment for Hunter Syndrome. Completed, enrolled 58 participants across 9 sites in 7 countries.
Detailed Summary
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome
CountriesAustralia, Canada, France, Mexico, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionSep 2017
TodayJul 2026
First PostedFeb 4, 2014
Enrollment StartMar 24, 2014
Primary CompletionSep 28, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.4 years ago
Interventions
idursulfase-ITbiological
10mg
No IT treatmentother
Standard of Care