NCT00144781View on ClinicalTrials.gov

A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

January 31, 2006

Study Completion Date

January 31, 2006

Conditions
Mucopolysaccharidosis IHurler's SyndromeHurler-Scheie SyndromeScheie Syndrome
Interventions
BIOLOGICAL

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)

0.58 mg/kg every week

BIOLOGICAL

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)

1.2 mg/kg every week

BIOLOGICAL

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)

1.2 mg/kg every other week

BIOLOGICAL

Aldurazyme (Recombinant Human Alpha-L-Iduronidase)

1.8 mg/kg every other week

Trial Locations (5)

CEP 88025-601

Hospital Infantil Joana de Gusmao, Florianópolis

CEP 30130-100

Universidade Federal de Minas Gerais, Belo Horizonte

CEP 90035-003

Hospital de Clinical de Porto Alegre, Porto Alegre

CEP 04023-062

Universidade Federal de Sao Paulo, São Paulo

M5G 1X8

Division of Clinical and Metabolic Genetics, Toronto

All Listed Sponsors
collaborator

BioMarin/Genzyme LLC

INDUSTRY

lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00144781 - A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease | Biotech Hunter | Biotech Hunter