Status:
COMPLETED
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:
PHASE2
Brief Summary
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion criteria will rec...
Eligibility Criteria
Inclusion
- Patients with corticosteroids over 20mg/day(Prednisolone) at informed consent.
- Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
- Patients who pemphigoid activity score is score1 and more before study medication received.
- Patients who symptom 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.
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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00809822
Start Date
November 1 2008
End Date
October 1 2010
Last Update
October 25 2010
Active Locations (1)
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1
Osaka, Japan