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Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients

NCT00146770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-04-03

Study results available
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Summary

This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.

Conditions

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

Interventions

BIOLOGICAL

Aldurazyme

Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks

BIOLOGICAL

Aldurazyme

0.58 mg/kg Aldurazyme every week for 208 weeks

BIOLOGICAL

placebo

Placebo for 26 weeks

Sponsors & Collaborators

  • BioMarin/Genzyme LLC

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2005-03-31
Completion
2005-03-31

Countries

  • United States
  • Brazil
  • Canada
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00146770 on ClinicalTrials.gov