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| Sponsor: | Genzyme |
|---|---|
| Collaborator: |
BioMarin/Genzyme LLC |
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00144768 |
Purpose
The purpose of this study is to determine whether the development of antibodies to Aldurazyme® (laronidase) in patients with MPS I receiving Aldurazyme® (laronidase) impairs the clearance of GAG substrate.
| Condition | Intervention | Phase |
|---|---|---|
|
Mucopolysaccharidosis I Hurler's Syndrome Hurler-Scheie Syndrome Scheie's Syndrome |
Drug: Aldurazyme® (laronidase) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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® (Laronidase). |
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
| Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
| United States, California | |
| Children's Hospital Los Angeles | Completed |
| Los Angeles, California, United States, 90027 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Completed |
| Hartford, Connecticut, United States, 06106 | |
| United States, Minnesota | |
| Regents of the University of Minnesota | Completed |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Wisconsin | |
| Medical College of Wisconsin, Inc. | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | ALID-020-03 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00144768 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metabolism, Inborn Errors Mucopolysaccharidoses Pathologic Processes Disease Metabolic Diseases Genetic Diseases, Inborn |
Lysosomal Storage Diseases Syndrome Connective Tissue Diseases Mucinoses Carbohydrate Metabolism, Inborn Errors Mucopolysaccharidosis I |