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Sponsored by: |
BioMarin Pharmaceutical |
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Information provided by: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00067470 |
The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.
Condition | Intervention | Phase |
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Mucopolysaccharidosis VI |
Drug: N-acetylgalactosamine 4-sulfatase |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | ASB-03-05 |
Study First Received: | August 20, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00067470 |
Health Authority: | United States: Food and Drug Administration |
Metabolism, Inborn Errors Mucopolysaccharidoses Metabolic Diseases Genetic Diseases, Inborn Lysosomal Storage Diseases |
Connective Tissue Diseases Mucopolysaccharidosis Metabolic disorder Mucopolysaccharidosis VI |
Mucinoses Carbohydrate Metabolism, Inborn Errors |