drugset / Trial / NCT02221271

Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

NCT02221271

Phase 3 Completed 22 enrolled Nihon Pharmaceutical Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluate the Functional Grade(FG) and Arm Grade(AG) et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.

Timeline

Start
2014-10
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 400 mg/kg Intravenous