At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 5 enrolled
Drug / intervention
Elaprasebiological
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 Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Safety and Efficacy of Idursulfase (r-DNA Origin) (Elaprase™) in Indian Pediatric and Adult Population With Hunter Syndrome (Mucopolysaccharidosis II)
In Brief
A Phase 4 clinical trial evaluating Elaprase for Hunter Syndrome. Completed, enrolled 5 participants across 5 sites.
Detailed Summary
The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome. Participants will receive Elaprase once per week over a 3-hour period which can be reduced to 1 hour as determined by the study doctor. Participants will need to visit the clinic weekly during the duration of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartApr 2022
Primary CompletionApr 2024
Study CompletionApr 2024
TodayJul 2026
First PostedSep 27, 2021
Enrollment StartApr 21, 2022
Primary CompletionApr 6, 2024
Study CompletionApr 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.8 years ago
Interventions
Elaprasebiological
Elaprase IV infusion.