NCT00144768

A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients

A Multicenter, Multinational, Open-Label Study of Anti-Laronidase Antibody Formation and Urinary GAG Levels in Patients With Mucopolysaccharidosis I (MPS I) Being Treated With Aldurazyme® (Laronidase).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.

Conditions

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

Interventions

Type	Name	Description
DRUG	laronidase	dose of 0.58mg/kg body weight IV every week

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-05
• Last updated: 2014-05-05

Locations

3 sites across 1 country: United States