NIPH Clinical Trials Search

UMIN ID: UMIN000000532

Registered date:01/12/2006

NPB-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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPemphigus
Date of first enrollment2004/11/01
Target sample size75
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)0mg/kg per day for 5 days(placebo) 200mg/kg per day for 5 days 400mg/kg per day for 5 days


Primary OutcomeDays up to protocol-off
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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

Related Information


public contact
Name toshikazu okuno
Address 3-8,Dosho-machi 2-chome,chuo-ku,Osaka 541-0045,Japan Japan
Affiliation NIHON PHARMACEUTICAL CO.,LTD Clinical Development Department
scientific contact
Name Koji Hashimoto
Address Shitsukawa,Toon,Ehime 791-0295,Japan Japan
Affiliation Ehime University Hospital Department of Dermatology