Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

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 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

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