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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

NCT01824251•Nihon Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. 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. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.

Eligibility

Age

20 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
•2\. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
•3\. Patients who need high-dose intravenous immunoglobulin therapy.
•4\. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
•5\. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria

•1\. Patients with evidence of myelopathy or demyelination of central nerve
•2\. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
•3\. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
•4\. Patients with multifocal motor neuropathy.
•5\. Patients treated with plasmapheresis at 3 months before informed consent.
•6\. Patients treated with rituximab at 6 months before informed consent.
•7\. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
•8\. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
•9\. Patients with history of shock or hypersensitivity for NPB-01.
•10\. Patients with IgA deficiency.
+8 more criteria

Locations (1)

Nihon Pharmaceutical Co., Ltd

Osaka, Japan

Key Dates

Start Date

April 1, 2013

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

January 20, 2016

Enrollment

ACTUAL participants

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

NPB-01

DRUG

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT06752356

Chronic Inflammatory Demyelinating Polyneuropathy

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

Inclusion Criteria

Exclusion Criteria

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

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