NCT02037347终止1 期
Palifermin Treatment of Toxic Epidermal Necrolysis
Brett King2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time-to-cutaneous Re-epithelialization
研究概览
简要总结
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis
- •Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia
- •Age of 18 years old or older
- •The patient is expected to survive longer than 48 hours
排除标准
- •Skin detachment above 90% of the body surface area
- •Skin detachment has not progressed during the previous 48 hours
- •A positive serum pregnancy test
- •Age < 18 years old
- •Known hematologic or solid organ malignancy
研究组 & 干预措施
Palifermin
Experimental
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
干预措施: Palifermin (Drug)
结局指标
主要结局
Time-to-cutaneous Re-epithelialization
时间窗: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days
次要结局
- Time-to-mucosal Re-epithelialization(The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days)
- Time-to-cessation of Epidermal Necrosis(The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days)
研究者
Brett King
Assistant Professor of Dermatology
Yale University
研究点 (2)
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