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 (Mucopolys
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 ]
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