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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)

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