Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

NCT ID: NCT02221271

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

Brief Summary

Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days.

Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.

Conditions

Guillain-Barré Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPB-01

Group Type: EXPERIMENTAL

NPB-01

Intervention Type: DRUG

Interventions

NPB-01

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.

2. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).

3. Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.

4. Patients with greater than or equal to 18 years old at informed consent.

Exclusion Criteria

1. Patients with history of shock for NPB-01.

2. Patients with history of hypersensitivity for NPB-01.

3. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.

4. Patients with malignancy at informed consent.

5. Patients treated with immune globulin at 8 weeks before informed consent.

6. Patients with IgA deficiency.

7. Patients with impaired liver function.

8. Patients with impaired renal function.

9. Patients with cerebro- or cardiovascular disorders.

10. Patients with high risk of thromboembolism.

11. Patients with hemolytic/hemorrhagic anemia.

12. Patients with decreased cardiac function.

13. Patients with decreased platelet.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nihon Pharmaceutical Co., Ltd

Osaka, , Japan

Countries

Japan

Other Identifiers

NPB-01-13/C-01

Identifier Type: -

Identifier Source: org_study_id