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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Nihon Pharmaceutical Co., Ltd
Osaka, Japan
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
Time frame: 28weeks
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.
Time frame: 52weeks
INCAT score
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
ISS
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
maximum grip strength
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
Medical Research Council(MRC) sum score
Time frame: 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
Time frame: 1,4,28,52weeks
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