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

Study Overview
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Brief Summary
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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
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Guillain-Barré Syndrome

Intervention / Treatment
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* Drug: NPB-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study). Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset. Patients with greater than or equal to 18 years old at informed consent. Exclusion Criteria: Patients with history of shock for NPB-01. Patients with history of hypersensitivity for NPB-01. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome. Patients with malignancy at informed consent. Patients treated with immune globulin at 8 weeks before informed consent. Patients with IgA deficiency. Patients with impaired liver function. Patients with impaired renal function. Patients with cerebro- or cardiovascular disorders. Patients with high risk of thromboembolism. Patients with hemolytic/hemorrhagic anemia. Patients with decreased cardiac function. Patients with decreased platelet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPB-01<br> | Drug: NPB-01<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks. |  | Baseline,4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days required for 1 grade improvement of the Hughes functional grading scale(FG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| days required for 2 grade improvement of the Hughes functional grading scale(FG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| changes in Hughes functional grading scale(FG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks. |  | Baseline,4weeks | 
| days required for 1 grade improvement of the Arm Grade(AG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| days required for 2 grade improvement of the Arm Grade(AG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| changes in Arm Grade(AG) |  | Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks | 
| changes in manual muscle testing(MMT) |  | Baseline,1,2,3,4,8,12 weeks | 
| changes in grip strength |  | Baseline,1,2,3,4,8,12 weeks | 
| changes in activity of daily living(ADL) |  | Baseline,1,2,3,4,8,12 weeks | 
| changes in electrophysiological findings |  | Baseline,4,12 weeks |