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

Phase 1/2 Completed 31 enrolled Green Cross Corporation

RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start: 2010-05
Primary completion: 2011-03
Completion: 2011-03

Publications

Sohn YB, Cho SY, Park SW, Kim SJ, Ko AR, Kwon EK, Han SJ, Jin DK. Phase I/II clinical trial of enzyme replacement therapy with idursulfase beta in patients with mucopolysaccharidosis II (Hunter syndrome). Orphanet J Rare Dis. 2013 Mar 18;8:42. doi: 10.1186/1750-1172-8-42.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC1111	Protein / enzyme biologic	0.5 mg/kg	Intravenous
Subject	GC1111	Protein / enzyme biologic	1 mg/kg	Intravenous
Comparator	idursulfase	Protein / enzyme biologic	0.5 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications