Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00712348
• Date of registration: 07/07/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
• Scientific title: A Phase 3 Multicenter, Open-label, Switchover Trial to Assess the Safety and Efficacy of Plant Cell Expressed Recombinant Human Glucocerebrosidase in Patients With Gaucher Disease Treated With Imiglucerase
• Date of first enrolment: December 2008
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00712348
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Israel, Serbia, Spain, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gaucher Disease

Intervention(s)

Drug: Taliglucerase alfa

Primary Outcome(s)

Hemoglobin [Time Frame: Every 3 months from Baseline to Month 9]

Secondary ID(s)

PB-06-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00712348