Clinical Trial: A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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® (Laroni
Brief 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.
Detailed Summary:
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome:
- Urinary GAG (glycosaminoglycans) [ Time Frame: Up to 4 years ]
- Immunogenicity Testing [ Time Frame: Up to 4 years ]
Original Primary Outcome: To evaluate clinical significance of anti-laronidase IgG antibody formation to Aldurazyme® (laronidase) therapy.
Current Secondary Outcome: Safety [ Time Frame: Up to 4 years ]
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: September 2, 2005
Date Started: July 2004
Date Completion:
Last Updated: May 2, 2014
Last Verified: April 2013
