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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01408550 |
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Date of registration:
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27/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
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Scientific title:
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NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III) |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01408550 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
2. Patients with continued treatment for bullous pemphigoid without add or change the
treatment after informed consent.
3. Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more
before study medication received.
4. Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before
study medication received.
5. Patients with twenty years old at informed consent.
6. Patients with hospitalization during five consecutive days of study medication and
seven consecutive days after administration of study medication .
Exclusion Criteria:
1. Patients treated with plasmapheresis at 28 days before informed consent.
2. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day)
at 14 days before informed consent.
3. Patients treated with intravenous immunoglobulin at 56 days before informed consent.
4. Patients who receive or adjust in increments immunosuppressants at 14 days before
informed consent.
5. Patients with malignancy or a history of this disease.
6. Patients with history of shock for NPB-01.
7. Patients with history of hypersensitivity for NPB-01.
8. Patients with IgA deficiency.
9. Patients with impaired liver function.
10. Patients with impaired renal function.
11. Patients with cerebro- or cardiovascular disorders.
12. Patients with high risk of thromboembolism.
13. Patients with hemolytic/hemorrhagic anemia.
14. Patients with decreased cardiac function.
15. Patients with decreased platelet.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bullous Pemphigoid
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Intervention(s)
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Drug: Placebo
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Drug: NPB-01
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Primary Outcome(s)
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The score using Pemphigus Disease Area Index (PDAI)
[Time Frame: 15 days]
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Secondary Outcome(s)
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Pemphigoid Activity Score
[Time Frame: 8 weeks]
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Oral Steroid dose
[Time Frame: 8 weeks]
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anti-BP180 antibody titers
[Time Frame: 8 weeks]
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Secondary ID(s)
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NPB-01-06/C-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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