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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT00144794 |
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Date of registration:
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02/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mucopolysaccharidosis I (MPS I) Registry
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Scientific title:
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Mucopolysaccharidosis I (MPS I) Registry |
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Date of first enrolment:
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November 20, 2003 |
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Target sample size:
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1500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00144794 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Czechia
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Denmark
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Egypt
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France
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Germany
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Hong Kong
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Hungary
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India
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Indonesia
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Ireland
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Italy
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Japan
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Korea, Republic of
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Kuwait
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Lebanon
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Malaysia
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Netherlands
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Pakistan
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Philippines
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Poland
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Portugal
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Romania
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Russian Federation
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Saudi Arabia
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Singapore
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Slovakia
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Sweden
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Taiwan
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Thailand
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United Arab Emirates
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United Kingdom
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United States
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Vietnam
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Contacts
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Name:
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For site information, send an email with site number to |
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Address:
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Telephone:
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Email:
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Contact-Us@sanofi.com |
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Affiliation:
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients with a confirmed diagnosis of MPS I are eligible for inclusion. Confirmed
diagnosis is defined as: A. documented biochemical evidence of a deficiency in alpha
(a)-L-iduronidase enzyme activity and/or B. mutation(s) in the gene coding for
a-L-iduronidase, or measurable clinical signs and symptoms of MPS I
- For all patients there should be a completed patient authorization form
Exclusion Criteria:
- No exclusion criteria for participation in the MPS I Registry. NOTE: Registry
participation does not exclude participation in other clinical studies.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mucopolysaccharidosis I (MPS I)
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Primary Outcome(s)
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To evaluate the long-term effectiveness of Aldurazyme
[Time Frame: Approximately 17 Years]
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Secondary ID(s)
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U1111-1294-8266
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DIREGC07008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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