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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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19 February 2015 |
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Main ID: |
NCT00125879 |
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Date of registration:
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01/08/2005 |
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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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Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602
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Scientific title:
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A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602 |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00125879 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Germany
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Israel
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Italy
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Netherlands
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Taiwan
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United States
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Contacts
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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:
- The patient's legal guardian(s) must provide written informed consent prior to any
study-related procedures being performed
- The patient and his/her legal guardian(s) must have the ability to comply with the
clinical protocol
- The patient must have completed Protocol AGLU01602.
Exclusion Criteria:
- Patient has experienced any unmanageable adverse event (AE) in Protocol AGLU01602 due
to Myozyme that would preclude continuing treatment with Myozyme
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glycogen Storage Disease Type II
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Intervention(s)
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Biological: Myozyme
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Primary Outcome(s)
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Long-term Safety and Efficacy
[Time Frame: 52 weeks]
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Secondary ID(s)
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AGLU02403
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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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