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) studied | Pemphigus |
| Date of first enrollment | 2004/11/01 |
| Target sample size | 75 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 0mg/kg per day for 5 days(placebo) 200mg/kg per day for 5 days 400mg/kg per day for 5 days |
Outcome(s)
| Primary Outcome | Days up to protocol-off |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | NIHON PHARMACEUTICAL CO.,LTD |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | NIHON PHARMACEUTICAL CO.,LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | toshikazu okuno |
| Address | 3-8,Dosho-machi 2-chome,chuo-ku,Osaka 541-0045,Japan Japan |
| Telephone | |
| Affiliation | NIHON PHARMACEUTICAL CO.,LTD Clinical Development Department |
| scientific contact | |
| Name | Koji Hashimoto |
| Address | Shitsukawa,Toon,Ehime 791-0295,Japan Japan |
| Telephone | |
| Affiliation | Ehime University Hospital Department of Dermatology |