Clinical Trial: Study of rhASB in Patients With Mucopolysaccharidosis VI
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Multinational Open-Label Extension Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With Mucopolysaccharidosis VI
Brief Summary: The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.
Detailed Summary:
Sponsor: BioMarin Pharmaceutical
Current Primary Outcome: 12-Minute Walk Test [ Time Frame: Baseline of ASB-03-05 through week 96 of ASB-03-06 ]
Original Primary Outcome: Lysosomal Storage Disease
Current Secondary Outcome:
- 3-Minute Stair Climb [ Time Frame: Baseline ASB-03-05 through week 96 of ASB-03-06. ]
- Change in Urinary Glycosaminoglycans (GAG) Level [ Time Frame: 72 weeks ]
Original Secondary Outcome:
Information By: BioMarin Pharmaceutical
Dates:
Date Received: February 24, 2005
Date Started: February 2004
Date Completion:
Last Updated: January 26, 2010
Last Verified: January 2010