drugset / Trial / NCT02342184

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

NCT02342184 ↗

Phase 3 Completed 21 enrolled Japan Blood Products Organization
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-08
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GB-0998 Protein / enzyme biologic 400 mg/kg Intravenous