PER-025-14已完成未知
SAFETY AND EFFICACY OF A LYSOPHOSPHATIDIC ACID RECEPTOR ANTAGONISTIN IDIOPATHIC PULMONARY FIBROSISA MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF THE SAFETY ANDEFFICACY OF BMS-986020 IN SUBJECTS WITH IDIOPATHIC PULMONARY FIBROSIS
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 17 人开始时间: 2014年7月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 80（—）
入选标准
- •A randomization must: 1) Be between 40 and 80 years. 2) Presenting clinical symptoms consistent with IPF before selection . 3) Have a diagnosis of interstitial pulmonary fibrosis ( UIP) or IPF usually obtained by high-resolution computed tomography ( HRCT ) or surgical lung biopsy (SLB ) . 4) extending the scan greater than the extent of the fibrotic changes emphysema . 5) Do not have any features to support an alternative diagnosis . 6) post-bronchodilator FVC percentage between 50% and 80 % estimated . 7) Submit the post- bronchodilator FVC between selection and day 1 which is smaller than a relative difference of 10%. 8) Having a DLCO between 30 % and 80 % , inclusive. 9) No evidence of improved measurements of IPF disease severity over the previous year . 10) You can walk 150 meters or more during the 6MWT on the seleccion.11 ) Sample decrease in oxygen saturation of 2 percentage points or more during the 6MWT . 12) Be able to understand and sign a consent form . 13) Able to understand treatment compliance and protocol 14) Women of reproductive age (WRA ) should use birth control .
- •( see protocol - section 3.2.1 page 29)
排除标准
- •1.Considerable clinical worsening of IPF between screening and day 1 (during the selection process ) . 2.Presents a ratio of forced expiratory volume in 1 second ( FEV1) / FVC less than 0.8 after administration of bronchodilator selection . 3. 12%Absolute increase or greater and an increase of 200 ml in FEV1, FVC , or both , after bronchodilator . 4.Clinically significant environmental exposure known to cause pulmonary fibrosis. 5.Exists known explanation for interstitial lung disease. 6. The patient has a clinical diagnosis of any disease of the connective tissue. 7.Has clinically significant asthma or chronic obstructive pulmonary disease. 8. Presented clinical evidence of active infection. 9. Has any history of malignancy requiring medical intervention or major surgery within the next 2 years . 10. Has any condition besides IPF , in the investigator´s opinion , is likely to cause death of the patient within the next 2 years . 11. Have a history of end-stage liver disease , end-stage renal disease requiring dialysis , history of heart disease or unstable or damaged (other than IPF) lung within 6 months. 12.The patient has used before BMS- 986020 or have a known hypersensitivity . 13 . In the investigator´s opinion , the patient is not a suitable candidate for enrollment or is unlikely to meet the requirements of this study. 14 . He has smoked cigarettes within 3 months of the selection made , or is not willing to avoid using products with snuff during the study. 15 . Expects to receive a lung transplant within 1 year.
- •(See protocol - Section 3.2.2 page 32)
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