Drugs / ISU302
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01881633 | Oct → Nov 2010 | Gaucher disease | ISU Abxis Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02770625 | Sep 2011 → Mar 2013 | Gaucher disease type I | ISU Abxis Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01161914 | Jan → Aug 2011 | Gaucher disease type I | ISU Abxis Co., Ltd. | Withdrawn | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ISU302 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02770625 ↗ |
| Known as | Imiglucerase for Injection | “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” NCT01161914 ↗ |
| Modality | Protein / enzyme biologic | “60 U/kg as an effective glucocerebrosidase enzyme replacement therapeutic product” NCT02770625 ↗ |
| Route | Intravenous | “administered by IV infusion for a dose of 60 U/kg” NCT01161914 ↗ |