Clinical Trial: Study of Idursulfase-beta (GC1111) in Hunter Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Idursulfase-beta (GC1111) in Hunter Syndrome (Same as current

Current Secondary Outcome:

• Change from baseline in urinary GAG at Week 25 [ Time Frame: Baseline to Week 25 ]
• Change from baseline in Six Minute Walk Test at Week 25 [ Time Frame: Baseline to Week 25 ]
• Percent change from baseline in Six Minute Walk Test at Week 25 [ Time Frame: Baseline to Week 25 ]
• Change from baseline in Liver volume at Week 25 [ Time Frame: Baseline to Week 25 ]
  Liver volume measured by MRI
• Percent change from baseline in Liver volume at Week 25 [ Time Frame: Baseline to Week 25 ]
  Liver volume measured by MRI
• Change from baseline in Spleen volume at Week 25 [ Time Frame: Baseline to Week 25 ]
  Spleen volume measured by MRI
• Percent change from baseline in Spleen volume at Week 25 [ Time Frame: Baseline to Week 25 ]
  Spleen volume measured by MRI
• Incidence of Adverse Events and Serious Adverse Events [ Time Frame: Baseline to Week 25 ]
• Safety changes from baseline in clinical laboratory tests, physical examination and vital signs [ Time Frame: Baseline to Week 25 ]
• Immunogenicity [ Time Frame: Baseline to Week 25 ]
  anti-drug-antibody
• Pharmacokinetic profile - Area under the serum concentration time curve (AUClast) [ Time Frame: 1 and 17 week ]
• Pharmacokinetic profile - Maximum observed peak plasma concentration (Cmax) [ Time Frame: 1 and 17 week ]
• Pharmacokinetic profile - Time at which Cmax is observed (Tmax) [ Time Frame: 1 and 17 week ]

Original Secondary Outcome: Same as current

Information By: Green Cross Corporation

Dates:
Date Received: January 17, 2016
Date Started: December 2016
Date Completion: June 2020
Last Updated: January 21, 2016
Last Verified: January 2016