Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.

Details

• Lead Sponsor: Pfizer; Protalix

Criteria

Inclusion Criteria:

• Males and females, 18 years or older

• Diagnosis of Gaucher disease treated historically with imiglucerase

• Able to provide written informed consent

Exclusion Criteria:

• Currently taking another experimental drug for any condition

• History of allergy to carrots

• Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions

• Allergy to beta-lactam antibiotics

• 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.