CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Idursulfasebiological
Likely dose
Idursulfase 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/NCT00607386
NCT00607386Phase 4Completed
CompareCT.gov

A Multi-Center, Open-Label Study Evaluating Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Enzyme Replacement Therapy

Shire·interventional·Posted Feb 5, 2008·Updated Jun 8, 2021

In Brief

A Phase 4 clinical trial evaluating Idursulfase for Hunter Syndrome and 2 related conditions. Completed, enrolled 28 participants across 3 sites in 3 countries.

Detailed Summary

The objective of this study is to determine the safety of once weekly dosing of idursulfase 0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHunter Syndrome, Mucopolysaccharidosis II, MPS II
CountriesBrazil, Poland, Taiwan
CollaboratorsCovance, PharmaNet, PRA Health Sciences

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2008
Enrollment StartDec 31, 2007
Primary CompletionJul 8, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.4 years ago

Interventions

Idursulfasebiological

Solution for intravenous infusion, 0.5 mg/kg weekly