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

NCT02342184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-02-04

No results posted yet for this study

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.

Conditions

  • Guillain-Barré Syndrome

Interventions

DRUG

GB-0998

Sponsors & Collaborators

  • Japan Blood Products Organization

    lead INDUSTRY

Principal Investigators

  • Kyoichi Nomura · Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02342184 on ClinicalTrials.gov