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

Information source: Genzyme
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie's Syndrome

Intervention: laronidase (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Genzyme

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme

Overall contact:
Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com

Summary

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

Clinical Details

Official title: A Multicenter, Multinational, Open-Label Study of Anti-Laronidase Antibody Formation and Urinary GAG Levels in Patients With Mucopolysaccharidosis I (MPS I) Being Treated With Aldurazyme (Laronidase).

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Urinary GAG (glycosamnioglycans)

Immunogenicity Testing

Secondary outcome: Safety

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com

Children's Hospital Los Angeles, Los Angeles, California 90027, United States; Completed

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Completed

Regents of the University of Minnesota, Minneapolis, Minnesota 55455, United States; Completed

Medical College of Wisconsin, Inc., Milwaukee, Wisconsin 53226, United States; Recruiting

Additional Information

Starting date: July 2004
Last updated: April 29, 2010

Page last updated: December 08, 2011

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