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Sponsors and Collaborators: |
Genzyme BioMarin/Genzyme LLC |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00144768 |
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 |
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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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | Active, not recruiting |
Los Angeles, California, United States, 90027 | |
United States, Connecticut | |
Connecticut Children's Medical Center | Active, not recruiting |
Hartford, Connecticut, United States, 06106 | |
United States, Minnesota | |
Regents of the University of Minnesota | Active, not recruiting |
Minneapolis, Minnesota, United States, 55455 | |
United States, Wisconsin | |
Medical College of Wisconsin, Inc. | Recruiting |
Milwaukee, Wisconsin, United States, 53226 |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | ALID-020-03 |
Study First Received: | September 2, 2005 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00144768 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Lysosomal Storage Diseases Mucopolysaccharidosis I Alpha-L-iduronidase deficiency Metabolism, Inborn Errors Mucopolysaccharidoses Antibodies |
Genetic Diseases, Inborn Connective Tissue Diseases Mucopolysaccharidosis Metabolic disorder Hurler syndrome Immunoglobulins |
Pathologic Processes Disease Syndrome Mucinoses Carbohydrate Metabolism, Inborn Errors |