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

NCT00144781 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-04-03

Study results available
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Summary

The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).

Conditions

  • Mucopolysaccharidosis I
  • Hurler's Syndrome
  • Hurler-Scheie Syndrome
  • Scheie 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

Sponsors & Collaborators

  • BioMarin/Genzyme LLC

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Information · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • Brazil
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00144781 on ClinicalTrials.gov