A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary… (NCT00144768) | Clinical Trial Compass
CompletedPhase 4
A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients
United States25 participantsStarted 2004-07
Plain-language summary
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.
Who can participate
SexALL
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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