Clinical Trial: Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Brief Summary:
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.
Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd
Current Primary Outcome: disease evaluation score [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- disease evaluation score [ Time Frame: 4 ,10 ,20 days ]
- avulsed skin area [ Time Frame: 20 days ]
- erythematous area [ Time Frame: 20 days ]
Original Secondary Outcome: Same as current
Information By: Nihon Pharmaceutical Co., Ltd
Dates:
Date Received: September 20, 2012
Date Started: October 2012
Date Completion:
Last Updated: July 1, 2014
Last Verified: October 2013
