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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPB-01 | Experimental | Intravenous immunoglobulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPB-01 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nihon Pharmaceutical Co., Ltd | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28768822 | Derived | Kuwabara S, Mori M, Misawa S, Suzuki M, Nishiyama K, Mutoh T, Doi S, Kokubun N, Kamijo M, Yoshikawa H, Abe K, Nishida Y, Okada K, Sekiguchi K, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I CIDP Study Group. Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2017 Oct;88(10):832-838. doi: 10.1136/jnnp-2017-316427. Epub 2017 Aug 2. |
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |