Systems medicine analysis of sarcoidosis by targeting mTOR in apilot study of sirolimus as treatment in patients with sarcoidosis

Medical University of Vienna0 个研究点目标入组 20 人开始时间: 2018年12月20日最近更新: 2022年1月24日

试验速览

暂无简介。

•1)Patients of full age (18 – 80 years old) that fulfil the ATS/ERS/WASOG diagnostic criteria for sarcoidosis and have a progressive disease and skin involvement (more than 3x3cm).
•2)Histologically proven sarcoidosis, diagnosed = 6 year prior to screening
•3)If immunosuppressants are taken at the time of screening, doses of these medications have to remain stable for =1 month (no additional immunosuppressants, no major alterations of the dosages) prior to the screening visit. During the study, background medication regimen and doses should remain stable until month 8, when tapering of oral glucocorticosteroids can be started.
•4)Written informed consent
•5)Compliance of the patients to follow instructions and appointments of the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1)Hypersensitivity / intolerance against sirolimus or other components of the medication, patients with an allergy against peanuts or soya
•2)Pregnancy, Lactation
•3)Concurrent malignancy
•4)Chronic or serious infections within 2 months prior screening
•5)Transplantation of an organ in the medical history

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