Pirfenidone for the reduction of pulmonary inflammatory and fibrogenic activity in patients with silicosis due to artificial stone and progressive massive fibrosis.

Fundación para la Gestión de la Investigación Biomédica de Cádiz0 个研究点目标入组 18 人开始时间: 2021年6月11日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•1. Age over 18 years and under 65.
•2. Man with a diagnosis of silicosis in the form of PMF by lung or lymph node biopsy, or by radiological criteria.
•3. History of exposure to silica in work with artificial can for at least 5 years.
•4. Patients capable of consenting to their participation in the study by providing written informed consent, or, if they are not trained, through a legal repressentative.
•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 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Participation in another clinical trial in the 6 months prior to the start of participation in this study.
•2. Hypersensitivity to any of the components of pirfenidone.
•3. Biological or farmacological treatment for any other disease or condition related to silicosis or PMF.
•4. Concomitant treatment with a drug that can causes pirfenidone interactions.
•5. Active infectious disease
•6. Any pathology that may condition the evolution of respiratory diseases, including cancer, HIV, HBV, HCV, liver cirrhosis, liver failure, severe kidney failure or any other that in the opinion of the investigator may interfere with the results of the study.
•7. Active smoking
•8. Laboratory test abnormalities at screening timepoint
•- Total bilirrubin >2 ULN
•- AST/SGOT or ALT/SGPT > 2.5 ULN
•- Alkaline phosphatase >3.0 ULN
•- Creatinine clearance <40 mL/min (Cockcroft-Gault)
•9. Concomitant treatments that may cause serious digestive events.
•10. Digestive surgery or similar procedures that may cause digestive intolerances.
•11. Not availability to complete all the trial visits
•12. Angiodema

发起方

Fundación para la Gestión de la Investigación Biomédica de Cádiz