NCT01301898

To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients

Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: Male
• Age: 6 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients

Conditions

• Mucopolysaccharidosis II

Interventions

Type	Name	Description
DRUG	GC1111_0.5mg/kg
DRUG	GC1111_1.0mg/kg
DRUG	Elaprase_0.5mg/kg

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-02-23
• Last updated: 2012-02-14

Locations

1 site across 1 country: South Korea