Status:
COMPLETED
Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion crite...
Eligibility Criteria
Inclusion
- Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
- Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
- Patients with twenty years old at informed consent.
- Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication .
Exclusion
- Patients treated with plasmapheresis at 28 days before informed consent.
- Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
- Patients treated with intravenous immunoglobulin at 56 days before informed consent.
- Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
- Patients with malignancy or a history of this disease.
- Patients with history of shock for NPB-01.
- Patients with history of hypersensitivity for NPB-01.
- Patients with IgA deficiency.
- Patients with impaired liver function.
- Patients with impaired renal function.
- Patients with cerebro- or cardiovascular disorders.
- Patients with high risk of thromboembolism.
- Patients with hemolytic/hemorrhagic anemia.
- Patients with decreased cardiac function.
- Patients with decreased platelet.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01408550
Start Date
August 1 2011
End Date
September 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
Osaka, Japan