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



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

For Condition: Mucopolysaccharidosis VI
Status: Recruiting
Sponsor(s): BioMarin Pharmaceutical ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 7 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patient consent - Patient must be seven years of age or older - Patient must have documented biochemical or genetic proof of MPS VI - The patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes of a screening 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 - The patient has clinically significant spinal cord compression - The patient has known hypersensitivity to rhASB or to components of the active or placebo test solutions
Total Enrollment: 

Location and Contact Information:

BioMarin Pharmaceutical, Inc. *Recruiting*
Novato,  California,  94949
United States
Recruiting Linda  Scott 415-884-6700


Additional Information:
Study ID Numbers:  ASB-03-05; 
Study Start Date: 
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067470

Other Mucopolysaccharidosis Vi Studies:
1. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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

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

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

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