Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Completed · Phase 3

Conditions studied: Gaucher Disease

In brief

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.

Key facts

Study ID

NCT00712348

Run by

Pfizer

People needed

31

Starts

2008-12-01

Expected to finish

2013-05-01

Last updated by the study team

2018-10-04

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Research Foundation for Lysosomal Storage Diseases, Inc. — Coral Springs, Florida, United States
• Department of Human Genetics, Emory University School of Medicine — Decatur, Georgia, United States
• Neurogenetics, NYU at Rivergate — New York, New York, United States
• Bone Marrow Transplant Service, The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Rambam Medical Center — Haifa, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel
• Sala de Hematologia, Hospital Universitario Miguel Servet — Zaragoza, Spain
• Lysosomal Disorders Service, Addenbrookes Hospital NHS Trust — Cambridge, United Kingdom
• Royal Free Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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