45
Participants
Start Date
December 31, 2000
Primary Completion Date
September 30, 2001
Study Completion Date
September 30, 2001
rhIDU (recombinant human-Alpha-L-Iduronidase)
Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 units/kg (approximately 0.58mg/kg) administered intravenously over approximately 4 hours once weekly for 26 weeks.
Placebo
Patients in the Placebo-control group were administered a solution of 100mM sodium phosphate , 150mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over a time period of approximately 4 hours once weekly for 26 weeks.
New York
Chapel Hill
Vancouver
Mainz
BioMarin/Genzyme LLC
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY