EUCTR2010-024251-87-GB进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 485
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 40 years;
- •IPF diagnosed, based upon most recent ATS/ERS/JRS/ALAT IPF guideline
- •within 5 years;
- •Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF;
- •Dlco (corrected for Hb): 30%-79% predicted of normal;
- •FVC = 50% predicted of normal
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN);
- •Airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 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 (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
- •Coagulation parameters: International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time
- •(PTT) by > 50% of institutional ULN);
- •Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months
- •N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
- •Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8
- •weeks of visit 1;
研究者
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