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

Phase 3

Completed

• Conditions: Guillain-Barré Syndrome
• Interventions: Drug: GB-0998

• Registration Number: NCT02342184
• Lead Sponsor: Japan Blood Products Organization

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-25
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. In principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms.
2. 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).
3. Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset.

Exclusion Criteria

1. Patients who have the anamnesis of shock or hypersensitivity to GB-0998.
2. Patients who have been diagnosed as hereditary fructose intolerance.
3. Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome.
4. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy.
5. Patients who have received treatment of malignant tumors.
6. Patients who were administered immunoglobulin within 8 weeks before informed consent.
7. Patients who have been diagnosed IgA deficiency in their past history.
8. Patients with severe renal disorder or decreased cardiac function.
9. Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases.
10. Patients with high risk of thromboembolism.
11. Pregnant, lactating, and probably pregnant patients.
12. Patients who were administered other investigational drug within 12 weeks before consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GB-0998	GB-0998	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)	4 weeks

Secondary Outcome Measures

Name	Time	Method
changes in activity of daily living (ADL)	1,2,4,8,12 weeks
changes in AG	1,2,3,4,6,8,12 weeks
days required for 1 grade improvement of the AG	1,2,3,4,6,8,12 weeks
days required for 1 grade improvement of 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 2 grade improvement of the AG	1,2,3,4,6,8,12 weeks
changes in grip strength	1,2,4,8,12 weeks
changes in motor nerve conduction velocity	4,12 weeks
changes in manual muscle testing (MMT)	1,2,4,8,12 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
changes in FG on rescue treatment	1,2,3,4,6,8,12 weeks

Trial Locations

Locations (1)

Department of Neurology, Saitama Medical Center, Saitama Medical University; 🇯🇵 Kawagoe, Saitama, Japan