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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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12 December 2020 |
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Main ID: |
NCT00962260 |
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Date of registration:
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18/08/2009 |
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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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Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
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Scientific title:
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An Open-label Expanded Access Trial of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease Who Require Enzyme Replacement Therapy |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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Recruitment status: |
No longer available |
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URL:
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https://clinicaltrials.gov/show/NCT00962260 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Countries of recruitment
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Israel
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females, 18 years or older
- Diagnosis of Gaucher disease treated historically with imiglucerase
- Able to provide written informed consent
Exclusion Criteria:
- Currently taking another experimental drug for any condition
- History of allergy to carrots
- Previous infusion reaction suspected to be allergic in nature to Cerezyme® or
Ceredase® or receiving premedication to prevent infusion reactions
- Allergy to beta-lactam antibiotics
- Presence of any medical, emotional, behavioral or psychological condition that in the
judgment of the Investigator would interfere with the patient'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: Plant cell expressed recombinant glucocerebrosidase (prGCD)
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Secondary ID(s)
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PB-06-004
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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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