Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

Status Completed

Clinical Trial Summary

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is an extension trial to Study NCT00376168 and NCT00712348.

Clinical Trial Description

This will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prGCD in patients completing NCT00376168. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the extension study will be fifteen months. There will be two treatment groups: 30 units/kg every 2 weeks or 60 units/kg every 2 weeks. ;

Study Design

Related Conditions & MeSH terms

Gaucher Disease

Clinical Trial Details

NCT number	NCT00705939
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	June 2008
Completion date	August 2013

View Details

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