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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 (

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

Detailed Summary:
Sponsor: Green Cross Corporation

Current Primary Outcome: Primary Outcome [ Time Frame: baseline, every 4 weeks ]

measurement of % change of Urine GAG


Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary Outcome [ Time Frame: baseline, every 12 weeks ]

  • Measurements of the six-minute-walk test (6-MWT)
  • Measurements of liver volume
  • Measurements of heart size and heart function
  • Measurements of joint range of motion
  • Measurements of urine GAG levels
  • Measurements of pulmonary function
  • Evaluate the safety: vital signs, physical examination, laboratory tests, adverse events, immunogenecity


Original Secondary Outcome: Same as current

Information By: Green Cross Corporation

Dates:
Date Received: February 22, 2011
Date Started: May 2010
Date Completion:
Last Updated: February 12, 2012
Last Verified: February 2012