CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
Aldurazyme +2 morebiological
Likely dose
0.58 mg/kg Aldurazyme intravenously every weekAI-extracted
Key inclusion· 3
  • ✓Patient must have successfully completed Study ALID-003-99 and received at least 21 of 26 consecutive weekly infusions
  • ✓No safety issues from prior study that would contraindicate participation in the extension
  • ✓Female patients of childbearing potential must have negative pregnancy test at entry
Key exclusion· 3
  • ✕Pregnant or lactating women
  • ✕Receipt of any investigational drug within 30 days prior to enrollment
  • ✕Serious intercurrent illness or medical condition that may significantly interfere with study compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00146770
NCT00146770Phase 3Completed
CompareCT.gov

A Multicenter, Multinational, Open-Label Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I

Genzyme, a Sanofi Company·interventional·Posted Sep 7, 2005·Updated Apr 3, 2015

In Brief

A Phase 3 clinical trial evaluating Aldurazyme and placebo for Mucopolysaccharidosis I and 3 related conditions. Completed, enrolled 45 participants across 25 sites in 7 countries.

Detailed Summary

This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome
CountriesBrazil, Canada, Germany, Italy, Netherlands, United Kingdom, United States
CollaboratorsBioMarin/Genzyme LLC

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartMay 1, 2001
Primary CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

Aldurazymebiological

Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks

Aldurazymebiological

0.58 mg/kg Aldurazyme every week for 208 weeks

placebobiological

Placebo for 26 weeks