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Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI



Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI

For Condition: Mucopolysaccharidosis VI
Status: No longer recruiting
Sponsor(s): BioMarin Pharmaceutical ,
Synopsis: The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with mucopolysaccharidosis VI (MPS VI)
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patient consent Patient must be five years of age or older Patient must have documented biochemical or genetic proof of MPS VI Patient must walk at least 1 meter, but less than 250 meters, in the first 6 minutes of the baseline 12-minute walk test If female of childbearing potential, patient must have a negative pregnancy test Exclusion Criteria: Patient is under consideration for or has undergone a successful bone marrow transplant (BMT). Pregnant or lactating patient Patient has received an investigational drug within 30 days prior to study enrollment Patient has been previously treated with rhASB Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance History of cancer (except low grade and fully resolved skin malignancy)
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  ASB-01-04; 
Study Start Date: 
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048711

Other Mucopolysaccharidosis Vi Studies:
1. Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI

2. Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI

3. Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients with MPS VI

4. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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