Back to resultsEfficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Primary Purpose
Guillain-Barré Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GB-0998
Sponsored by
About this trial
This is an interventional treatment trial for Guillain-Barré Syndrome
Eligibility Criteria
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.
Sites / Locations
- Department of Neurology, Saitama Medical Center, Saitama Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GB-0998
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
Secondary Outcome Measures
days required for 1 grade improvement of FG
days required for 2 grade improvement of FG
changes in FG
proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline
days required for 1 grade improvement of the AG
days required for 2 grade improvement of the AG
changes in AG
changes in grip strength
changes in manual muscle testing (MMT)
changes in activity of daily living (ADL)
changes in motor nerve conduction velocity
changes in FG on rescue treatment
Full Information
NCT ID
NCT02342184
First Posted
December 25, 2014
Last Updated
February 3, 2016
Sponsor
Japan Blood Products Organization
1. Study Identification
Unique Protocol Identification Number
NCT02342184
Brief Title
Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Official Title
Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Japan Blood Products Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barré Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GB-0998
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GB-0998
Other Intervention Name(s)
Venoglobulin-IH
Primary Outcome Measure Information:
Title
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
days required for 1 grade improvement of FG
Time Frame
1,2,3,4,6,8,12 weeks
Title
days required for 2 grade improvement of FG
Time Frame
1,2,3,4,6,8,12 weeks
Title
changes in FG
Time Frame
1,2,3,4,6,8,12 weeks
Title
proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline
Time Frame
4weeks
Title
days required for 1 grade improvement of the AG
Time Frame
1,2,3,4,6,8,12 weeks
Title
days required for 2 grade improvement of the AG
Time Frame
1,2,3,4,6,8,12 weeks
Title
changes in AG
Time Frame
1,2,3,4,6,8,12 weeks
Title
changes in grip strength
Time Frame
1,2,4,8,12 weeks
Title
changes in manual muscle testing (MMT)
Time Frame
1,2,4,8,12 weeks
Title
changes in activity of daily living (ADL)
Time Frame
1,2,4,8,12 weeks
Title
changes in motor nerve conduction velocity
Time Frame
4,12 weeks
Title
changes in FG on rescue treatment
Time Frame
1,2,3,4,6,8,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoichi Nomura
Organizational Affiliation
Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology, Saitama Medical Center, Saitama Medical University
City
Kawagoe
State/Province
Saitama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome
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