PB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3)
Not Applicable
- Conditions
- Pemphigus
- Registration Number
- JPRN-UMIN000000532
- Lead Sponsor
- IHON PHARMACEUTICAL CO.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients treated with Plasmapheresis 2)Patients treated with corticosteroids pulse therapy (methylpredonizolone over 0.5g/day) 3)Patients received intravenous immunoglobulin 4) Patients with history of shock for NPB-01 5)Patients with history of Hypersensitivity for NPB-01 6)Patients with IgA deficiency 7)Patients with impaired liver function 8)Patients with impaired renal function 9)Patients with cerebro- or cardiovascular disorders or a history of these disorders 10)Patients with a high risk of thromboembolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Days up to protocol-off
- Secondary Outcome Measures
Name Time Method