An observational, PractIce based, Open label, Non-comparative, multicEnterstudy to Evaluate the efficacy, toleRability and safety of pirfenidone in idiopathicpulmonary fibrosis [PIONEER] - PIONEER

Cipla Ltd0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Note: No Age limit is given in protocol.
•1. Written, signed, dated and ethics committee approved data sharing consent obtained from patients before performing any procedures.
•2. Patients diagnosed with IPF as per the ATS/ERS/JRS/ALAT criteria 2011guidelines:
•a. Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
•b. The presence of a UIP pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy.
•c. Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy.

•1.Patients who have received pirfenidone for more than one year before the start of the study.
•2.Pregnant or lactating women.
•3.Known allergy or hypersensitivity to Pirfenidone or any components of the medication
•4.Concomitant use of fluvoxamine
•5.Severe hepatic impairment or end stage liver disease
•6.Severe renal impairment (CrCl less than 30 ml/min) or end stage renal disease requiring dialysis

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