A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG Levels in Aldurazyme® Treated Patients - NCT00144768-53226 (Clinical Trial 128007)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy128007.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Mucopolysaccharidosis I - Hurler's Syndrome - Hurler-Scheie Syndrome - Scheie's Syndrome |
| Purpose: |
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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.
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| Study summary: |
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| 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 |
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| Study is available at: |
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Medical College of Wisconsin, Inc.
Milwaukee, WI 53226
United States
Primary Contact:
Medical Information
Email: medinfo@genzyme.com
Phone: 800-745-4447 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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