CTRI/2011/12/002248已完成3 期
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 6
- 主要终点
- Annual rate of decline in FVC expressed in mL over 52 weeks
研究概览
简要总结
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis. Total number patients proposed to be recruited from India is 20. First subject is expected to be enrolled on 17 January 2012
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 40 years IPF diagnosed according to most recent American Thoracic Society European Respiratory Society Japanese Respiratory Society Latin American Thoracic Association IPF guideline for diagnosis and management within 5 years Combination of High Resolution Computerized Tomography pattern and if available surgical lung biopsy pattern as assessed by central reviewers are consistent with diagnosis of IPF Dlco that is corrected for Hb is 30%-79% predicted of normal FVC more than or equal to 50% predicted of normal.
排除标准
- •Aspartate Aminotransferase Alanine Aminotransferase more than 1.5 x Upper Limit of Normal ULN Bilirubin more than 1.5 x ULN Relevant airways obstruction that is pre bronchodilator FEV1/FVC less than 0.7 Patient likely to have lung transplantation during study being on transplantation list is acceptable for participation Myocardial infarction within 6 months Unstable angina within 1 month Bleeding risk that is genetic predisposition or fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy or history of hemorrhagic CNS event within 12 months haemoptysis or haematuria or active gastrointestinal bleeding or ulcers or major injury or surgery within 3 months Thrombotic risk that is inherited predisposition history of thrombotic event including stroke and transient ischemic attacks within 12 months International normalised ratio more 2, prolongation of prothrombin time and partial thromboplastin time by more than 50 percent of institutional ULN N-ACetyl Cystein, prednisone more than 15mg per day or equivalent received within 2 weeks of visit 1 Pirfenidone or azathioprine or cyclophosphamide or cyclosporine A received within 8 weeks of visit 1.
结局指标
主要结局
Annual rate of decline in FVC expressed in mL over 52 weeks
时间窗: 52 weeks
次要结局
- Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points).(52 weeks)
- Time to first acute exacerbation (days)(52 weeks)
- Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).(52 weeks)
- Further analyses on FVC- Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks Absolute categorical change of FVC percent up to 52 weeks: decrease by more than 5, increase by more than 5, and change within equal to 5(52 weeks)
- Time to death or lung transplant.(52 weeks)
- Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).(52 Weeks)
- On-treatment survival (on-treatment based on fatal adverse event + 28 days).(52 weeks)
- Acute exacerbations: Proportion of patients with at least one acute exacerbation during the 52 weeks. Exacerbation days (defined by number of days with an exacerbation per patient) during the 52 weeks. Number of exacerbations during the 52 weeks(52 weeks)
- Patient reported outcomes- changes in SGRQ, Shortness Of Breath Questionnaire (SOBQ), Cough And Sputum Assessment (CASAQ), Patients Global Impression of Change (PGIC), EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D), up to 52 weeks(52 weeks)
研究者
研究点 (6)
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