Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Inclusion criteria

• Patients who the disease evaluation score is more than 14 at study medication received.
• Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
• Patients with treatment effect is insufficiency before study medication received and need additional treatment.
• Patients aged more than twenty years old at informed consent.

Exclusion criteria

• Patients who the SCORTEN score is more than 4 at study medication received.
• Patients with multiple organ failure at study medication received.
• Patients with severe respiratory disorder at study medication received.
• Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
• Patients with malignancy during treatment at informed consent.
• Patients treated with corticosteroids dosage is change at 2 days before study medication received.
• Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2 days before study medication received.
• Patients treated with plasmapheresis at 2 days before study medication received.
• Patients treated with high-dose intravenous immunoglobulin at 28 days before informed consent.
• Patients with history of shock or hypersensitivity for NPB-01.
• Patients with IgA deficiency.
• Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et al.
• Patients with more than 2mg/dL serum creatinine.
• Patients with severe cerebro- or cardiovascular disorders.
• Patients with high risk of thromboembolism.
• Patients with hemolytic/hemorrhagic anemia.
• Patients with severe decreased cardiac function.
• Patients with decreased platelet less than 75,000/μL..