- Males and females 2 to
- Diagnosis of Gaucher disease with leukocyte acid β-glucosidase activity ≤30% of the
mean of the reference range for healthy subjects.
- Subjects who have not received enzyme replacement therapy (ERT) in the past or who
have not received ERT in the past 12 months and have a negative
anti-glucocerebrosidase antibody assay.
- Subjects who have not received substrate reduction therapy (SRT) in the past 12
months.
- Subjects whose clinical condition, in the opinion of the investigator, requires
treatment with enzyme replacement therapy (ERT).
- Currently taking another investigational drug for any condition.
- Presence of neurological signs and symptoms characteristic of Gaucher disease with
complex neuronopathic features other than longstanding oculomotor gaze palsy.
- Presence of unresolved anemia due to iron, folic acid, or vitamin B12 deficiency
- Previous hypersensitivity reaction to Cerezyme® (imiglucerase) or Ceredase®
(alglucerase).
- History of allergy to carrots.
- Presence of HIV, HBsAg or hepatitis C infections.
- Subject's parent(s) or legal guardian(s) are unable to understand the nature, scope
and possible consequences of the study.
- 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.