A Switch-Over Study of the Safety and Efficacy of ISU302 in Patients With Type 1 Gaucher Disease

Inclusion Criteria: * Patient diagnosed with type-1 Gaucher disease * Patient who was stably treating Gaucher disease with Cerezyme® and who was maintaining the usage and dosage of Cerezyme® for at least 6 months prior to study drug administration * Patient aged 2 years or higher * Female patient with contraception during the study period (oral or injectable contraceptive hormones, intrauterine device, physical devices using condom, sponge form, jelly, and femidom, and abstinence) * Patient who signed the informed consent form after hearing the detailed explanation about this study * Definition of the stable treatment of type-1 Gaucher disease: * No neurologic deficit * Normal hemoglobin concentration, and platelet count that has increased to ≥100,000/㎣, or maintained to 100,000/㎣ * Normal or no deteriorated bone mineral density * Normal or no deteriorated splenomegaly or hepatomegaly Exclusion Criteria: * Patient who participated in other clinical studies within 90 days before study drug administration * Patient with unstable hemoglobin and platelet counts for at least 6 months before study drug administration * Patient with hypersensitivity to Cerezyme® * Patient positive to HIV antibody, hepatitis B antigen, and hepatitis C antibody * Patient with Fe, folic acid, or vitamin B12-deficcient anemia * Patient who received miglustat within 6 months before study drug administration * Patient who received erythrocyte growth factor or chronic systemic corticosteroids within 6 months before study drug administration * Patient who had clinically significant splenic obstruction within 12 months before study drug administration * Pregnant or lactating patient * Patient who had serious concurrent diseases such as infectious diseases or drug-addicted patient * Patient who was considered inappropriate for this study by the investigators or sub-investigators