Clinical trial NCT02342184: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Guillain-Barré Syndrome
Lead sponsor: Japan Blood Products Organization
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
timeFrame: 4 weeks
Secondary outcomes:
measure: days required for 1 grade improvement of FG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: days required for 2 grade improvement of FG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: changes in FG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline
timeFrame: 4weeks
measure: days required for 1 grade improvement of the AG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: days required for 2 grade improvement of the AG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: changes in AG
timeFrame: 1,2,3,4,6,8,12 weeks
measure: changes in grip strength
timeFrame: 1,2,4,8,12 weeks
measure: changes in manual muscle testing (MMT)
timeFrame: 1,2,4,8,12 weeks
measure: changes in activity of daily living (ADL)
timeFrame: 1,2,4,8,12 weeks
measure: changes in motor nerve conduction velocity
timeFrame: 4,12 weeks
measure: changes in FG on rescue treatment
timeFrame: 1,2,3,4,6,8,12 weeks
Other outcomes:
Locations:
city: Kawagoe
country: Japan
facility: Department of Neurology, Saitama Medical Center, Saitama Medical University
state: Saitama
Study officials:
affiliation: Department of Neurology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
name: Kyoichi Nomura
role: STUDY_CHAIR
References: