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Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Last updated on March 15, 2019

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Study Location
University Research Foundation for Lysosomal Storage Diseases, Inc.
Coral Springs, Florida, 33065 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gaucher Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00712348
Pfizer
Completed
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

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