Isu302 (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
---|---|---|
19 | Lysosomal storage disease | 3 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT02770625 (ClinicalTrials.gov) | September 2011 | 7/5/2016 | Phase III Study of ISU302 in Patients With Type 1 Gaucher Disease | A Multicenter, Open-Label Phase III Study to Evaluate the Safety and Efficacy of ISU302 (Imiglucerase for Injection) in Patients With Type 1 Gaucher Disease | Gaucher Disease, Type 1 | Drug: ISU302 | ISU Abxis Co., Ltd. | NULL | Completed | 2 Years | N/A | All | 8 | Phase 3 | NULL |
2 | NCT01161914 (ClinicalTrials.gov) | January 2011 | 11/7/2010 | The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease | A Multi-national Randomized Double Blinded Phase III Study to Evaluate the Safety and Efficacy of ISU302(Imiglucerase for Injection) or Cerezyme in Patient With Type I Gaucher Disease | Gaucher Disease | Drug: Cerezyme®;Drug: ISU302 | ISU Abxis Co., Ltd. | NULL | Withdrawn | 2 Years | 75 Years | Both | 0 | Phase 3 | NULL |
3 | NCT01881633 (ClinicalTrials.gov) | October 2010 | 14/6/2013 | A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers | A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers | Gaucher Disease | Drug: ISU302;Drug: Placebo | ISU Abxis Co., Ltd. | NULL | Completed | 20 Years | 45 Years | Male | 24 | Phase 1 | NULL |