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

Completed · Phase 4

Conditions studied: Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie's Syndrome

In brief

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.

Key facts

Study ID

NCT00144768

Run by

Genzyme, a Sanofi Company

People needed

25

Starts

2004-07-01

Expected to finish

2007-05-01

Last updated by the study team

2014-05-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Childrens Hospital Los Angeles — Los Angles, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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