Status:
COMPLETED
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
Lead Sponsor:
Pfizer
Conditions:
Gaucher Disease
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme...
Detailed Description
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) ERT. E...
Eligibility Criteria
Inclusion
- Males and females, 2 years or older
- Confirmed diagnosis of Gaucher disease by the enzymatic activity assay
- Stable Gaucher disease
- Treatment with imiglucerase (Cerezyme®) for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least the last six months
- Able to provide written informed consent
Exclusion
- Currently taking another experimental drug for any condition
- History of allergy to carrots
- History of allergy to beta lactam antibiotics
- Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions
- Presence of HIV and/or HBsAg and/or hepatitis C infection
- Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency
- Presence of any significant comorbidity that could confound the interpretation of the clinical response to taliglucerase alfa
- 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 :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00712348
Start Date
December 1 2008
End Date
May 1 2013
Last Update
October 4 2018
Active Locations (10)
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1
University Research Foundation for Lysosomal Storage Diseases, Inc.
Coral Springs, Florida, United States, 33065
2
Department of Human Genetics, Emory University School of Medicine
Decatur, Georgia, United States, 30033
3
Neurogenetics, NYU at Rivergate
New York, New York, United States, 10016
4
Bone Marrow Transplant Service, The Royal Melbourne Hospital
Parkville, Victoria, Australia