CTRI/2017/02/007867已完成4 期
An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis - PASS IPF
Boehringer Ingelheim India Pvt Ltd0 个研究点目标入组 21 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients with documented diagnosis of IPF based upon ATS ERS JRS ALAT 2011 guidelines
- •and who comply with inclusion and exclusion criteria will be included in this active
- •surveillance The diagnosis of IPF as per ATS ERS JRS ALAT 2011 guidelines requires
- •Exclusion of other known causes of ILD eg domestic and occupational environmental
- •exposures connective tissue disease and drug toxicity
- •The presence of a UIP pattern on HRCT in patients not subjected to surgical lung biopsy
- •Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to
- •surgical lung biopsy
- •Patients with IPF IPFtreatment naïve or pretreated who are newly prescribed nintedanib according to the package insert
- •Willing and able to provide the informed consent
- •Patients in whom further visit/contact is possible during the planned period of active
- •surveillance
- •In addition equal number of consecutive IPF patients with documented diagnosis of IPF
- •based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone
- •will be enrolled
- •Patients with IPF IPF treatment naïve or pretreated who are newly prescribed
- •pirfenidone
- •Willing and able to provide informed consent to collect the baseline characteristics
排除标准
- •Patients who have taken nintedanib before participation in this active surveillance
- •Patients who are being treated with pirfenidone
- •Patients who are participating in a clinical trial or other IPF registries
- •In addition equal number of consecutive IPF patients with documented diagnosis of IPF
- •based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone
- •will be enrolled
- •Patients who have taken pirfenidone before participation in this active surveillance
- •Patients who are participating in a clinical trial or other IPF registries
研究者
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