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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 January 2016
Main ID:  NCT01824251
Date of registration: 01/04/2013
Prospective Registration: Yes
Primary sponsor: Nihon Pharmaceutical Co., Ltd
Public title: Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Scientific title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Date of first enrolment: April 2013
Target sample size: 49
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01824251
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 100 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Drug: NPB-01
Primary Outcome(s)
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [Time Frame: 52weeks]
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. [Time Frame: 28weeks]
Secondary Outcome(s)
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]
Secondary ID(s)
NPB-01-09/C-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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