A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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laronidase

dose of 0.58mg/kg body weight IV every week

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Alpha-L-Iduronidase, Aldurazyme®

Eligibility Criteria

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Inclusion Criteria

* Have a documented diagnosis of MPS I confirmed by measurable signs and symptoms and deficient α-L-iduronidase activity (\<10% of the lower limit of normal).
* For a patients receiving Aldurazyme therapy prior to study entry: Have available as baseline data the results of urinary GAG levels and IgG antibody titers collected prior to the patient's first Aldurazyme infusion.
* Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years.

Exclusion Criteria

* Have previously received Aldurazyme without the collection of baseline samples as specified.
* Have a suspected hypersensitivity to Aldurazyme or a know hypersensitivity to components of infusion solution.
* Have received a Hematopoietic Stem Cell Transplantation, injection fibroblast therapy, or major organ transplant.
* Are receiving chronic immunosuppressant therapy.
* Have a medical condition, serious intercurrent illness, or other extenuating circumstances that may interfere with study compliance including all prescribed evaluations and follow-up activities.
* Are pregnant or lactating
* Have received investigational drug within 30 days prior to study enrollment

Eligible Sex

ALL

Accepts Healthy Volunteers

No