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

January 17, 2016 updated by: Nihon Pharmaceutical Co., Ltd

NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Nihon Pharmaceutical Co., Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPB-01
Intravenous immunoglobulin
Drug: NPB-01
Other Names:
  • Intravenous immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
Time Frame: 28weeks
28weeks
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.
Time Frame: 52weeks
52weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
INCAT score
Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
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
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
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
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
1,4,28,52weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon Pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 17, 2016

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPB-01-09/C-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Inflammatory Demyelinating Polyneuropathy

Clinical Trials on NPB-01

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe