Brief Title
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Official Title
NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
Secondary Outcome
INCAT score
Condition
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention
NPB-01
Study Arms / Comparison Groups
NPB-01
Description: Intravenous immunoglobulin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
49
Start Date
April 2013
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
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. - 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.
Gender
All
Ages
20 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01824251
Organization ID
NPB-01-09/C-01
Responsible Party
Sponsor
Study Sponsor
Nihon Pharmaceutical Co., Ltd
Study Sponsor
, ,
Verification Date
October 2014