Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 replacement therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Protalix

Criteria

Inclusion Criteria:

• 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:

• 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