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

NCT01301898 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-02-14

No results posted yet for this study

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

DRUG

GC1111_0.5mg/kg

DRUG

GC1111_1.0mg/kg

DRUG

Elaprase_0.5mg/kg

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01301898 on ClinicalTrials.gov