Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

NPB-01

Drug
Who is being recruted

Autoimmune Diseases+11

+ Chronic Disease

+ Demyelinating Diseases

From 20 to 100 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 20, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01824251
Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: January 20, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesChronic DiseaseDemyelinating DiseasesImmune System DiseasesNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesPeripheral Nervous System DiseasesPolyneuropathiesPolyradiculoneuropathyPathological Conditions, Signs and SymptomsAutoimmune Diseases of the Nervous SystemDisease AttributesPolyradiculoneuropathy, Chronic Inflammatory Demyelinating

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
18 exclusion criteria prevent from participating
1. Patients with evidence of myelopathy or demyelination of central nerve
10. Patients with IgA deficiency
11. Patients with malignancy at informed consent
12. Patients with impaired liver function
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intravenous immunoglobulin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Nihon Pharmaceutical Co., Ltd

Osaka, JapanOpen Nihon Pharmaceutical Co., Ltd in Google Maps
CompletedOne Study Center