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