Clinical Trial: Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome

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

Official Title: Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome

Brief Summary: This study will carry out to assess the efficacy of GB-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to assess the safety of GB-0998.

Detailed Summary:
Sponsor: Japan Blood Products Organization

Current Primary Outcome: Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • days required for 1 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • days required for 2 grade improvement of FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in FG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline [ Time Frame: 4weeks ]
  • days required for 1 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • days required for 2 grade improvement of the AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in AG [ Time Frame: 1,2,3,4,6,8,12 weeks ]
  • changes in grip strength [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in manual muscle testing (MMT) [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in activity of daily living (ADL) [ Time Frame: 1,2,4,8,12 weeks ]
  • changes in motor nerve conduction velocity [ Time Frame: 4,12 weeks ]
  • changes in FG on rescue treatment [ Time Frame: 1,2,3,4,6,8,12 weeks ]


Original Secondary Outcome: Same as current

Information By: Japan Blood Products Organization

Dates:
Date Received: December 25, 2014
Date Started: August 2014
Date Completion:
Last Updated: February 3, 2016
Last Verified: December 2015