drugset / Trial / NCT02663024
Study of Idursulfase-beta (GC1111) in Hunter Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.
Timeline
- Start
- 2016-12
- Primary completion
- 2019-12
- Completion
- 2020-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hunterase | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |
| Subject | Hunterase | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Hunterase | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Subject | idursulfase | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |