CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Elaprase for intravenous (IV) infusiondrug
Likely dose
Elaprase for intravenous (IV) infusion 0.5 mg/kgfrom 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/NCT02455622
NCT02455622Phase 4Completed
CompareCT.gov

A Long-Term, Open-Label, Multicenter, Phase IV Study to Assess Longitudinal Changes on Height and Weight in Patients With MPS II Who Are Receiving Elaprase and Started Treatment With Elaprase at <6 Years of Age

Shire·interventional·Posted May 28, 2015·Updated Apr 2, 2026

In Brief

A Phase 4 clinical trial evaluating Elaprase for intravenous (IV) infusion for Hunter Syndrome. Completed, enrolled 21 participants across 8 sites in 8 countries.

Detailed Summary

This long-term study will provide Elaprase treatment to children enrolled in this study and will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient registry data to conduct the primary growth analysis to assess changes in height and weight in patients with Mucopolysaccharidosis II (Hunter syndrome) MPS II.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome
CountriesDominican Republic, Germany, Malaysia, Philippines, Serbia, Thailand, United States, Vietnam
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 28, 2015
Enrollment StartOct 28, 2015
Primary CompletionJul 29, 2025
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 11.1 years ago

Interventions

Elaprase for intravenous (IV) infusiondrug

Patients enrolled in this study will receive once-weekly IV infusions of Elaprase at a dose of 0.5 mg/kg and will be followed for a minimum of 5 years after initiation of Elaprase treatment, or until they reach their 10th birthday, whichever is longer.Height and weight data from HOS will be utilized in the Primary Growth Analysis for this study.