CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
rhIDU (recombinant human-Alpha-L-Iduronidase) +1 morebiological
Likely dose
rhIDU (recombinant human-Alpha-L-Iduronidase) 100 unitsfrom 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/NCT00912925
NCT00912925Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Multinational, Clinical Study of Recombinant Human Alpha L-Iduronidase In Patients With Mucopolysaccharidosis I

Genzyme, a Sanofi Company·interventional·Posted Jun 3, 2009·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating rhIDU (recombinant human-Alpha-L-Iduronidase) and Placebo for Mucopolysaccharidosis I and 2 related conditions. Completed, enrolled 45 participants across 4 sites in 3 countries.

Detailed Summary

This study is being conducted to demonstrate the safety and clinical efficacy of Aldurazyme treatment in MPS I patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis I, Hurlers Syndrome, Hurler-Scheie Syndrome
CountriesCanada, Germany, United States
CollaboratorsBioMarin/Genzyme LLC

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2009
Enrollment StartDec 1, 2000
Primary CompletionSep 1, 2001
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.1 years ago

Interventions

rhIDU (recombinant human-Alpha-L-Iduronidase)biological

Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 units/kg (approximately 0.58mg/kg) administered intravenously over approximately 4 hours once weekly for 26 weeks.

Placebobiological

Patients in the Placebo-control group were administered a solution of 100mM sodium phosphate , 150mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over a time period of approximately 4 hours once weekly for 26 weeks.