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

Guillain-Barré Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221271
• Other study ID #: NPB-01-13/C-01
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2014
• Last updated: April 11, 2017
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• NPB-01

Locations

Country	Name	City	State
Japan	Nihon Pharmaceutical Co., Ltd	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.		Baseline,4weeks
Secondary	days required for 1 grade improvement of the Hughes functional grading scale(FG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	days required for 2 grade improvement of the Hughes functional grading scale(FG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	changes in Hughes functional grading scale(FG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.		Baseline,4weeks
Secondary	days required for 1 grade improvement of the Arm Grade(AG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	days required for 2 grade improvement of the Arm Grade(AG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	changes in Arm Grade(AG)		Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
Secondary	changes in manual muscle testing(MMT)		Baseline,1,2,3,4,8,12 weeks
Secondary	changes in grip strength		Baseline,1,2,3,4,8,12 weeks
Secondary	changes in activity of daily living(ADL)		Baseline,1,2,3,4,8,12 weeks
Secondary	changes in electrophysiological findings		Baseline,4,12 weeks