At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Recombinant human arylsulfatase Abiological
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.
A Phase I/II Multicenter Open-label Dose Escalation Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy
In Brief
A Phase 2 clinical trial evaluating Recombinant human arylsulfatase A for Metachromatic Leukodystrophy (MLD). Completed, enrolled 24 participants across 5 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetachromatic Leukodystrophy (MLD)
CountriesAustralia, Denmark, France, Germany, Japan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartFeb 2012
Primary CompletionJan 2017
TodayJul 2026
First PostedJan 13, 2012
Enrollment StartFeb 2, 2012
Primary CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 14.5 years ago
Interventions
Recombinant human arylsulfatase Abiological
6 patients treated with HGT-1110 EOW by IT injection