Phase III Clinical Trial of NPB-01 in 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.
Toxic Epidermal Necrolysis
Drug: Intravenous immunoglobulin
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.|
- disease evaluation score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- disease evaluation score [ Time Frame: 4 ,10 ,20 days ] [ Designated as safety issue: No ]
- avulsed skin area [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- erythematous area [ Time Frame: 20 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696500
|Nihon Pharmaceutical Co., Ltd|
|Tokyo, Japan, 101-0031|