Status:
COMPLETED
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility:
All Genders
20-100 years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
- 11\. Patients with malignancy at informed consent.
- 12\. Patients with impaired liver function.
- 13\. Patients with impaired renal function.
- 14\. Patients with cerebro- or cardiovascular disorders.
- 15\. Patients with high risk of thromboembolism.
- 16\. Patients with hemolytic/hemorrhagic anemia.
- 17\. Patients with decreased cardiac function.
- 18\. Patients with decreased platelet.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01824251
Start Date
April 1 2013
End Date
September 1 2015
Last Update
January 20 2016
Active Locations (1)
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1
Nihon Pharmaceutical Co., Ltd
Osaka, Japan