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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: 16 December 2017
Main ID:  NCT01845584
Date of registration: 26/04/2013
Prospective Registration: Yes
Primary sponsor: Nihon Pharmaceutical Co., Ltd
Public title: Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.
Scientific title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.
Date of first enrolment: May 2013
Target sample size: 7
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01845584
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Japan
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients who become positive for anti-aquaporin 4 antibody or have becomed.

2. Patients who have developed myelitis.

3. Patients who run beyond greater than 30 days at least from last time in relapse.

4. Patients who new neurological symptom or worsening neurological symptom or flared
neurological symptom have sustained 24 hours at least not associated fever or
infection.

5. Patients who have an acute exacerbation at informed consent.

6. Patients who need steroid plus therapy(1g/day for five consecutive days).

7. Patients who can start steroid plus therapy within 3 days after informed consent.

8. Patients who be inadequate to effect to steroid plus therapy.

9. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria:

1. Patients who have developed optic neuritis.

2. Patients treated with intravenous immunoglobulin within 14 days before informed
consent.

3. Patients with malignancy at informed consent.

4. Patients with history of shock or hypersensitivity for NPB-01.

5. Patients with IgA deficiency.

6. Patients with impaired liver function.

7. Patients with impaired renal function.

8. Patients with cerebro- or cardiovascular disorders.

9. Patients with high risk of thromboembolism.

10. Patients with hemolytic/hemorrhagic anemia.

11. Patients with decreased cardiac function.

12. Patients with decreased platelet.



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Neuromyelitis Optica Spectrum Disorder
Intervention(s)
Drug: NPB-01
Primary Outcome(s)
Change from Baseline anti-aquaporin 4 antibody at 29 days [Time Frame: 29 days]
Change from Baseline Expanded Disability Status Scale (EDSS)/ Functional Systems (FS) at 29 days [Time Frame: 29 days]
Change from Baseline Quantification of nerve and spinal cord impairment (QOSI) at 29 days [Time Frame: 29 days]
Secondary Outcome(s)
Secondary ID(s)
NPB-01-08/E-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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