JPRN-jRCT2091220096已完成2 期
multicenter lymphangioleiomyomatosis sirolimus trial for safety - MLSTS
Koh Nakata, MD, PhD0 个研究点目标入组 65 人开始时间: 2012年8月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
Sirloins two year medication inhibits the deterioration of lung function in patients with mild LAM as well as moderate to severe LAM which was confirmed by MILES trial previously. O those improved, the improvement of lung function was remarkable in patients with history of chylothorax.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- Female
入选标准
- •a. written informed consent
- •b. diagnosis of LAM by chest HRCT
排除标准
- •a. history of myocardial infarction, angina or stroke
- •b. pregnant, breastfeeding or plans to become pregnant
- •c. unable or unwilling to use adequate contraception
- •d. significant hematologic or hepatic abnormality
- •e. intercurrent infection or HBV career
- •f. any surgery within 8 weeks of initiation of study drug
- •g. uncontrolled hyperlipidemia
- •h. previous lung transplant or currently on lung transplant list
研究者
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