NL-OMON37976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 Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) - BIBF 1120 in IPF, phase III
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
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
- 18 至 99（—）
入选标准
- •Written informed consent, Age ><= 40 years; IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 5 years; Dlco (corrected for Hb): 30%-79% predicted of normal; FVC * 50% predicted of normal.
排除标准
- •Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN); Relevant 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);Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; International normalised ratio (INR) > 2; prolongation of prothrombin time (PT) and partial thromboplastin time(PTT) by > 50% of institutional ULN);N-Acetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1; Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8weeks of visit 1.
研究者
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