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LAMにおけるシロリムスの有効性と安全性
基本情報
- NCT ID
- NCT00414648
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 89
- 治験依頼者名
- University of Cincinnati
概要
Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung. These cells invade lung tissue, including the airways, blood vessels, and lymph vessels, and restrict the flow of air, blood, and lymph, respectively. Respiratory failure, lung collapse (pneumothorax), and pleural effusions (chylothorax) are hallmarks of the disease. This study will evaluate the safety and effectiveness of sirolimus, an inhibitor of the mTOR pathway, in stabilizing or improving lung function in people with LAM.
対象疾患
Lymphangioleiomyomatosis
介入
Sirolimus(DRUG)
Placebo(DRUG)
依頼者(Sponsor)
実施施設 (2)
National Kinki-Chou Hospital
Sakai, Osaka, Japan
新潟大学医歯学総合病院
Niigata, Japan