Stevens-Johnson Syndrome Clinical Trial
Official title:
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were
confirmed based on the investigators national diagnostic criteria. Patients who meet all
inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01
(intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy
of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be
evaluated the disease evaluation score et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
events by 20 days after the start of the study treatment.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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