NCT03920540

A Study of GC1111 in Hunter Syndrom Patients

Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: Male
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Conditions

• Hunter Syndrome

Interventions

Type	Name	Description
COMBINATION_PRODUCT	GC1111	GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
COMBINATION_PRODUCT	Comparator	Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

Timeline

• Start date: 2017-03-09
• Primary completion: 2022-02-15
• Completion: 2022-02-15
• First posted: 2019-04-19
• Last updated: 2024-04-16

Locations

1 site across 1 country: South Korea