Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT01824251
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
100 Years
Study:
NCT01824251
Study Brief:
Protocol Section:
NCT01824251