EUCTR2018-001781-41-NL进行中（未招募）1 期
Evaluation of safety and tolerability of pirfenidone in asbestosis, a multicenter study - PIRF-asbestosis
ederlandse Vereniging van Artsen voor longziekten en Tuberculose0 个研究点目标入组 10 人开始时间: 2018年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients (40-85 years) with confirmed asbestosis by Dutch NVALT IPF expertise-panel (History of asbestos exposition with 15-30 years latency
- •AND pleural plaques OR asbestos fibers in pulmonary lavage OR asbestos fibers confirmed in lung biopsy), AND criteria 1-6
- •1. written informed consent
- •2. FVC = 50% predicted, DLCO = 25%
- •3. Minimal 6 minute walk test distance 150 meter
- •4. FEV1/FVC > 0.70
- •5. Documented disease progression in 3-6 months (absolute of relative FVC decrease > 5% in 3-6 months or absolute or relative DLCOc decrease > 10% in 3-6 months, or decrease = 25 meter on 6 minute walk test in 3-6 months)
- •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 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. current smoker
- •2. > 15% emphysema on HRCT thorax
- •3. >10mg prednisone daily or other immunosuppressant (MTX, azathioprine, cyclophosphamide)
- •4. malignancy
- •5. Hepatic impairment (History of hepatic impairment, elevation of transaminase enzymes, or the confirmation of any of the following liver function test criteria above the specified limits: Total bilirubin above the upper limit of normal (ULN), Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × ULN, Alkaline phosphatase > 2.0 × ULN)
- •6. Renal impairment (GFR < 30 ml/min or dialysis)
- •7.Pregnancy
- •8.Concomitant use of a strong and selective inhibitor of CYP1A2 (Fluvoxamin, enoxacin)
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