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

NCT02221271 | Completed Phase 3

• 1 other identifier: NPB-01-13/C-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.

  Baseline,4weeks

Secondary Outcomes (11)

• 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

• 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

• changes in Hughes functional grading scale(FG)

  Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks

• proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.

  Baseline,4weeks

• 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

Study Arms (1)

NPB-01

EXPERIMENTAL

Drug: NPB-01

Interventions

NPB-01 DRUG

NPB-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
• 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).
• Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
• Patients with greater than or equal to 18 years old at informed consent.

You may not qualify if:

• Patients with history of shock for NPB-01.
• Patients with history of hypersensitivity for NPB-01.
• 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.
• Patients with malignancy at informed consent.
• Patients treated with immune globulin at 8 weeks before informed consent.
• Patients with IgA deficiency.
• Patients with impaired liver function.
• Patients with impaired renal function.
• Patients with cerebro- or cardiovascular disorders.
• Patients with high risk of thromboembolism.
• Patients with hemolytic/hemorrhagic anemia.
• Patients with decreased cardiac function.
• Patients with decreased platelet.

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (1)

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 20, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

JP (1)