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

Sponsor

Nihon Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01824251

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy	Drug: NPB-01	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NPB-01 Intravenous immunoglobulin	Drug: NPB-01 Other Names: Intravenous immunoglobulin

Arm

Intervention/Treatment

Experimental: NPB-01

Intravenous immunoglobulin

Drug: NPB-01

Other Names:

Intravenous immunoglobulin

Outcome Measures

Primary Outcome Measures

proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. [28weeks]
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [52weeks]

Secondary Outcome Measures

INCAT score [1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks]
ISS [1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks]
maximum grip strength [1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks]
Medical Research Council（MRC） sum score [1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks]
the amplitude of the compound muscle action potential of the most severely affected motor nerve [1,4,28,52weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.
1. 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.)
1. Patients who need high-dose intravenous immunoglobulin therapy.
1. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
1. 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
1. 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）
1. 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.
1. Patients with multifocal motor neuropathy.
1. Patients treated with plasmapheresis at 3 months before informed consent.
1. Patients treated with rituximab at 6 months before informed consent.
1. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
1. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
1. Patients with history of shock or hypersensitivity for NPB-01.
1. Patients with IgA deficiency.
1. Patients with malignancy at informed consent.
1. Patients with impaired liver function.
1. Patients with impaired renal function.
1. Patients with cerebro- or cardiovascular disorders.
1. Patients with high risk of thromboembolism.
1. Patients with hemolytic/hemorrhagic anemia.
1. Patients with decreased cardiac function.
1. Patients with decreased platelet.