NCT00144781

A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Mucopolysaccharidosis I
• Hurler's Syndrome
• Hurler-Scheie Syndrome
• Scheie Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Aldurazyme (Recombinant Human Alpha-L-Iduronidase)	0.58 mg/kg every week
BIOLOGICAL	Aldurazyme (Recombinant Human Alpha-L-Iduronidase)	1.2 mg/kg every week
BIOLOGICAL	Aldurazyme (Recombinant Human Alpha-L-Iduronidase)	1.2 mg/kg every other week
BIOLOGICAL	Aldurazyme (Recombinant Human Alpha-L-Iduronidase)	1.8 mg/kg every other week

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-09-05
• Last updated: 2015-04-03
• Results posted: 2009-06-16

Locations

5 sites across 2 countries: Brazil, Canada