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

Guillain-Barré Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342184
• Other study ID #: B211-13
• Status: Completed
• Phase: Phase 3
• First received: December 25, 2014
• Last updated: February 3, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Japan Blood Products Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Guillain-Barré Syndrome
• Syndrome

Intervention

Drug:
• GB-0998

Locations

Country	Name	City	State
Japan	Department of Neurology, Saitama Medical Center, Saitama Medical University	Kawagoe	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Japan Blood Products Organization

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)		4 weeks	No
Secondary	days required for 1 grade improvement of FG		1,2,3,4,6,8,12 weeks	No
Secondary	days required for 2 grade improvement of FG		1,2,3,4,6,8,12 weeks	No
Secondary	changes in FG		1,2,3,4,6,8,12 weeks	No
Secondary	proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline		4weeks	No
Secondary	days required for 1 grade improvement of the AG		1,2,3,4,6,8,12 weeks	No
Secondary	days required for 2 grade improvement of the AG		1,2,3,4,6,8,12 weeks	No
Secondary	changes in AG		1,2,3,4,6,8,12 weeks	No
Secondary	changes in grip strength		1,2,4,8,12 weeks	No
Secondary	changes in manual muscle testing (MMT)		1,2,4,8,12 weeks	No
Secondary	changes in activity of daily living (ADL)		1,2,4,8,12 weeks	No
Secondary	changes in motor nerve conduction velocity		4,12 weeks	No
Secondary	changes in FG on rescue treatment		1,2,3,4,6,8,12 weeks	No