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Immune Tolerance Study With Aldurazyme® (Laronidase)

NCT00741338 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-07-02

Study results available
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Summary

The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.

Conditions

  • Mucopolysaccharidosis I

Interventions

BIOLOGICAL

Laronidase

0.058 mg/kg - 0.58 mg/kg IV infusion weekly.

DRUG

Cyclosporine A (CsA)

Orally three times daily.

DRUG

Azathioprine (Aza)

Orally either every day for Cohort 1 or every other day for Cohort 2.

Sponsors & Collaborators

  • BioMarin/Genzyme LLC

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Brazil
  • Russia

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 NCT00741338 on ClinicalTrials.gov