Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

December 31, 2000

Primary Completion Date

September 30, 2001

Study Completion Date

September 30, 2001

Conditions
Mucopolysaccharidosis IHurlers SyndromeHurler-Scheie Syndrome
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (4)

Unknown

New York

Chapel Hill

Vancouver

Mainz

All Listed Sponsors
collaborator

BioMarin/Genzyme LLC

INDUSTRY

lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00912925 - Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I | Biotech Hunter | Biotech Hunter