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A Phase 4 Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG Levels in Aldurazyme® (Laronidase) Treated Patients. - Article


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Asperger's Syndrome

Asperger Syndrome; Asperger//'s syndrome; Asperger///'s syndrome


Clinical Trial: A Phase 4 Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG Levels in Aldurazyme® (Laronidase) Treated Patients.

This study is currently recruiting patients.
Verified by Genzyme September 2005

Sponsors and Collaborators: Genzyme
BioMarin/Genzyme LCC
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00144768

Purpose

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.
Condition Intervention Phase
Mucopolysaccharidosis I
Hurler''''s Syndrome
Hurler-Scheie Syndrome
Scheie Syndrome
 Drug: Recombinant Human Alpha-L-Iduronidase, Aldurazyme® (laronidase)
Phase IV

MedlinePlus related topics:  Metabolic Disorders

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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).

Further Study Details: 
Primary Outcomes: To evaluate clinical significance of anti-laronidase IgG antibody formation to Aldurazyme® (laronidase) therapy.

Study start: July 2004;  Expected completion: July 2011
Last follow-up: December 2010;  Data entry closure: March 2011

Eligibility

Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Have a document 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 30days prior to study enrollment

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00144768

Medical Information      800-745-4447    medinfo@genzyme.com
Medical Information      617-252-7832    medinfo@genzyme.com

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

More Information

Study ID Numbers:  ALID-020-03
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144768
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


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Page Updated: September 6, 2005
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