NCT02449616已完成3 期
Evaluation of Repeat Administration of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC-E): An Open-Label Safety Extension Trial Assessing Repeat Administration of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis
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
- 16
- 试验地点
- 9
- 主要终点
- Safety as measured as the incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.
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
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed participation in study MST-188-01 (EPIC study)
- •Subject age 4 through 65 years
- •Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia
- •Subject requires hospitalization
排除标准
- •Subject has acute chest syndrome
- •Subject's laboratory results indicate inadequate organ function
- •Subject is pregnant or nursing an infant
- •Subject had a painful crisis requiring hospitalization within the preceding 14 days
- •Subject has been transfused within the past 14 days
- •Subject has complications related to SCD
研究组 & 干预措施
Study Drug
Experimental
MST-188
干预措施: MST-188 (Drug)
结局指标
主要结局
Safety as measured as the incidence of adverse events
时间窗: 30 days after administration of study drug
次要结局
- Rate of re-hospitalization for recurrence of VOC(Within 14 days of the date of discharge)
- Occurrence of acute chest syndrome(Within 120 hours of registration)
研究者
研究点 (9)
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