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| Sponsored by: |
BioMarin Pharmaceutical |
| Information provided by: | BioMarin Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00048620 |
Purpose
The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.
| Condition | Intervention | Phase |
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Mucopolysaccharidosis VI |
Drug: N-acetylgalactosamine 4-sulfatase |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind,2 Dose Group Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI |
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| BioMarin Pharmaceutical Inc. | |||||
| Novato, California, United States, 94949 | |||||
| BioMarin Pharmaceutical |
| Study Director: | Stuart J Swiedler, MD, Ph.D. | BioMarin Pharmaceutical |
More Information
Related Info 
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| Study ID Numbers: | ASB-00-01 |
| First Received: | November 4, 2002 |
| Last Updated: | November 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00048620 |
| Health Authority: | United States: Food and Drug Administration |
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