Status:
COMPLETED
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
Lead Sponsor:
Pfizer
Conditions:
Gaucher Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase...
Detailed Description
This will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prGCD in patients completing NCT00376168. Patients will receive IV infusion of prGCD eve...
Eligibility Criteria
Inclusion
- Successful completion of Protocol PB-06-001
- The patient signs informed consent
Exclusion
- Currently taking another experimental drug for any condition
- Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
- Pregnant or nursing
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00705939
Start Date
June 1 2008
End Date
August 1 2013
Last Update
October 4 2018
Active Locations (11)
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1
Department of Human Genetics, Emory University School of Medicine
Decatur, Georgia, United States, 30033
2
Neurogenetics, NYU at Rivergate
New York, New York, United States, 10016
3
Bone Marrow Transplant Service, The Royal Melbourne Hospital
Parkville, Victoria, Australia
4
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5