NCT01696500已完成3 期
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- disease evaluation score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •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..
研究组 & 干预措施
NPB-01
Experimental
干预措施: Intravenous immunoglobulin (Drug)
结局指标
主要结局
disease evaluation score
时间窗: 7 days
次要结局
- disease evaluation score(4 ,10 ,20 days)
- avulsed skin area(20 days)
- erythematous area(20 days)
研究者
研究点 (1)
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