EUCTR2006-002875-42-IT进行中（未招募）不适用
A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.
BOEHRINGER ING.0 个研究点目标入组 550 人开始时间: 2007年8月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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
- •- Patient >= 40 years - Written informed consent signed prior to entry into the study - IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit. - HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis. - FVC >= 50 % of predicted value Predicted normal values will be calculated according to ESCS: Males : FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34 Females : FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89 - Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted . Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline.Adjustment for haemoglobin: Males : DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb]) Females : DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g·dL-1 - PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •- AST, ALT > 1.5 x ULN at screening (visit 1). - Bilirubin > 1.5 x ULN at screening (visit 1). - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7) at screening(visit 1). - Continuous oxygen supplementation at randomisation (defined as >= 15 hours supplemental oxygen per day). - Active infection at screening or randomisation. - Neutrophils < 1500 / mm3 at screening(visit 1). - International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN at screening (visit 1). - Platelets < 100 000 /mL at screening (visit 1). - Haemoglobin < 9.0 g/dL at screening (visit 1). - In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation). - Life expectancy for disease other than IPF < 2.5 years (Investigator assessment). - Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial. Myocardial infarction during the previous 6 months Unstable angina during the previous month - Other investigational therapy received within 8 weeks prior to screening visit. - Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment (highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner). Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. - Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential). - Known or suspected active alcohol or drug abuse. - Bleeding risk Known inherited predisposition to bleeding. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc). Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. History of hemorrhagic CNS event within 12 months prior to screening (visit 1). Any of the following within 3 months prior to screening (visit 1): -Gross / frank haemoptysis or haematuria -Active gastro-intestinal bleeding or ulcers -Major injury or surgery. - Thrombotic risk Known inherited predisposition to thrombosis. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months prior to screening (visit 1). - Surgical procedures planned to occur during trial period. - Coagulopathy. - Uncontrolled systemic arterial hypertension.
研究者
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