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

NCT02221271 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

  • Guillain-Barré Syndrome

Interventions

DRUG

NPB-01

Sponsors & Collaborators

  • Nihon Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

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 NCT02221271 on ClinicalTrials.gov