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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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1 May 2023 |
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Main ID: |
NCT01422187 |
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Date of registration:
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22/08/2011 |
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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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A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
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Scientific title:
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A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01422187 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
- The subject signs an informed consent
Exclusion Criteria:
- Currently taking another investigational drug for any condition.
- Presence of any medical, emotional, behavioral or psychological condition that in the
judgment of the Investigator would interfere with the subject's compliance with the
requirements of the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gaucher Disease
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Intervention(s)
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Drug: Taliglucerase alfa
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Primary Outcome(s)
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Spleen Volume
[Time Frame: 60 months]
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Secondary Outcome(s)
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Platelet Count
[Time Frame: 60 months]
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Hemoglobin
[Time Frame: 60 months]
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Liver Volume
[Time Frame: 60 months]
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Secondary ID(s)
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PB-06-007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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