CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Aldurazyme (Recombinant Human Alpha-L-Iduronidase) +3 morebiological
Likely dose
0.58 mg/kg, 1.2 mg/kg weekly, or 1.2–1.8 mg/kg every other week (dose-optimization study with multiple arms)AI-extracted
Key inclusion· 3
  • ✓Documented diagnosis of MPS I confirmed by clinical signs/symptoms AND fibroblast or leukocyte α-L-iduronidase enzyme activity level <10% of lower limit of normal range
  • ✓Body weight at least 12.5 kg
  • ✓Serum creatinine and blood urea nitrogen (BUN) values within age-appropriate normal ranges
Key exclusion· 6
  • ✕Prior Aldurazyme (laronidase) exposure
  • ✕Suspected or known hypersensitivity to Aldurazyme or its components
  • ✕Prior hematopoietic stem cell transplantation (HSCT) or other major organ transplantation
  • ✕Surgery within 30 days prior to enrollment or anticipated surgery during study

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

Search/NCT00144781
NCT00144781Phase 4Completed
CompareCT.gov

A Multicenter, Multinational, Randomized, Dose-Optimization Study of the Safety and Pharmacodynamic Response of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I

Genzyme, a Sanofi Company·interventional·Posted Sep 5, 2005·Updated Apr 3, 2015

In Brief

A Phase 4 clinical trial evaluating Aldurazyme (Recombinant Human Alpha-L-Iduronidase) for Mucopolysaccharidosis I and 3 related conditions. Completed, enrolled 34 participants across 5 sites in 2 countries.

Detailed Summary

The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome
CountriesBrazil, Canada
CollaboratorsBioMarin/Genzyme LLC

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartDec 1, 2004
Primary CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)biological

0.58 mg/kg every week

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)biological

1.2 mg/kg every week

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)biological

1.2 mg/kg every other week

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)biological

1.8 mg/kg every other week