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

Green Cross Corporation1 site in 1 country31 target enrollmentMay 2010

ConditionsMucopolysaccharidosis II

InterventionsGC1111_0.5mg/kg GC1111_1.0mg/kg Elaprase_0.5mg/kg

DrugsGC1111_0.5mg/kg GC1111_1.0mg/kg Elaprase_0.5mg/kg

Overview

Phase: Phase 1
Intervention: GC1111_0.5mg/kg
Conditions: Mucopolysaccharidosis II
Sponsor: Green Cross Corporation
Enrollment: 31
Locations: 1
Primary Endpoint: Primary Outcome
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Green Cross Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with diagnosis of MPS II based on both clinical and biochemical criteria
•Male, ages 6 to 35 years old
•Patients who are able to comply with the study requirements
•Patients who have given voluntary written consent to participate in the study
•Patients who is acceptable for using an appropriate method of contraception

Exclusion Criteria

•History of a tracheostomy or a bone marrow transplant
•Known hypersensitivity to idursulfase
•Known shock to idursulfase
•History of receiving treatment with another investigational therapy within the past 30 days
•History of a stem cell transplant
•Known hypersensitivity to any of the components of idursulfase