An investigator driven, randomised, placebo controlled, double blind, multi-centre study to assess the safety and efficacy of RAD (Everolimus) in the treatment of pulmonary fibrosis

Dr Monique Malouf0 个研究点目标入组 120 人开始时间: 2005年10月5日最近更新: 2020年1月13日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 120

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 75 Years（—）
性别: All

入选标准

•A diagnosis of pulmonary fibrosis who are eligible to receive RAD. Patients capable of understanding the purposes and risks of the study and who give informed written consent.

排除标准

•i. Patients receiving immunosuppression other than study medication. NB patients receiving a mean dose of 10mg Prednisolone / day or steroid equivalent and who have been on a stable dose for at least 4 weeks will be allowed entry into the trial. ii. Pregnant women, nursing mothers.iv.Female/Male patients unwilling to maintain adequate birth-control during and for 3 months following the conclusion of study.iv. Patients with active malignancies or a history of malignancy with a recurrence free interval of 5 years (except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully).v. Patients with serological evidence of HIV, HbsAg or HCV antibodies.vi. Patients with respiratory failure requiring invasive ventilation.vii.Patients with systemic infections requiring therapy at the time of entry into the study. A systemic infection is defined as a body temperature of 38 degrees or above on 2 occasions, or 39 degrees accompanied by a positive culture of body fluid regarded as significant by the local laboratory which requires antibiotic therapy.viii. Patients with a concomitant major illness such as (a) cardiac or (b) renalinsufficiency (creatinine clearance 0ml/min).ix. Patients with severe uncontrolled hypercholesterolemia (9.1 mmol/L) (350mg/dL) or hypertriglyceridemia (5.6 mmol/L) (500mg/dL).x. Patients with a history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation. Low dose aspirin will be allowed.

研究者

发起方

Dr Monique Malouf

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