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

Study Overview
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Brief Summary
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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.

Official Title
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NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Conditions
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Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis

Intervention / Treatment
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* Drug: Intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPB-01<br> | Drug: Intravenous immunoglobulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease evaluation score |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease evaluation score |  | 4 ,10 ,20 days | 
| avulsed skin area |  | 20 days | 
| erythematous area |  | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVIG in Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Patients with Stevens-Johnson syndrome, Toxic Epidermal Necrolysis unresponsive to corticosteroids