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

Study Overview
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Brief Summary
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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.

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

Conditions
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Guillain-Barré Syndrome

Intervention / Treatment
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* Drug: GB-0998


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms. Patients with predominant motor neuropathy and FG is grade 4 or grade 5 (if symptoms is progressive, patients with FG is grade 3 involve in this study). Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset. Exclusion Criteria: Patients who have the anamnesis of shock or hypersensitivity to GB-0998. Patients who have been diagnosed as hereditary fructose intolerance. Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy. Patients who have received treatment of malignant tumors. Patients who were administered immunoglobulin within 8 weeks before informed consent. Patients who have been diagnosed IgA deficiency in their past history. Patients with severe renal disorder or decreased cardiac function. Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases. Patients with high risk of thromboembolism. Pregnant, lactating, and probably pregnant patients. Patients who were administered other investigational drug within 12 weeks before consent.

Ages Eligible for Study
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Minimum Age: 16 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: GB-0998<br> | Drug: GB-0998<br> <br> * Other names: Venoglobulin-IH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days required for 1 grade improvement of FG |  | 1,2,3,4,6,8,12 weeks | 
| days required for 2 grade improvement of FG |  | 1,2,3,4,6,8,12 weeks | 
| changes in FG |  | 1,2,3,4,6,8,12 weeks | 
| proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline |  | 4weeks | 
| days required for 1 grade improvement of the AG |  | 1,2,3,4,6,8,12 weeks | 
| days required for 2 grade improvement of the AG |  | 1,2,3,4,6,8,12 weeks | 
| changes in AG |  | 1,2,3,4,6,8,12 weeks | 
| changes in grip strength |  | 1,2,4,8,12 weeks | 
| changes in manual muscle testing (MMT) |  | 1,2,4,8,12 weeks | 
| changes in activity of daily living (ADL) |  | 1,2,4,8,12 weeks | 
| changes in motor nerve conduction velocity |  | 4,12 weeks | 
| changes in FG on rescue treatment |  | 1,2,3,4,6,8,12 weeks |