临床试验/NCT01217125

NCT01217125已完成4 期

CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS

Fundacio Puigvert0 个研究点目标入组 18 人开始时间: 2008年10月1日最近更新: 2012年3月8日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 18
主要终点: Angiomyolipoma volume

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.

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: 10 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years

排除标准

•Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

结局指标

主要结局

Angiomyolipoma volume

时间窗: 2 years

Measured by MRI

次要结局

skin lesions, AML complications,(2 years)

研究者

发起方

Fundacio Puigvert

申办方类型

Other

责任方

Principal Investigator

主要研究者

Roser Torra

MD, PhD

Fundacio Puigvert

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