EUCTR2015-003360-37-BE进行中（未招募）1 期
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) - Nintedanib in PF-ILD
SCS Boehringer Ingelheim Comm. V0 个研究点目标入组 600 人开始时间: 2016年12月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- •1.Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the study (and prior to any study procedure including shipment of HRCT to reviewer).
- •2.Male or female patients aged = 18 years at Visit 1.
- •3.Patients with physician diagnosed ILD who fulfil at least one of the following criteria for PF-ILD within 24 months of screening visit (Visit 1) despite treatment with unapproved medications used in clinical practice to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):
- •a.Clinically significant decline in FVC % pred based on a relative decline of =10%
- •b.Marginal decline in FVC % pred based on a relative decline of =5-<10% combined with worsening of respiratory symptoms
- •c.Marginal decline in FVC % pred based on a relative decline of =5-<10% combined with increasing extent of fibrotic changes on chest imaging
- •d.Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
- •[Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus].
- •4.Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10%, performed within 12 months of Visit 1 as confirmed by central readers.
- •5.For patients with underlying CTD: stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
- •6.DLCO corrected for Haemoglobin (Hb) [visit 1] = 30% and <80% predicted of normal at Visit 2.
- •7.FVC = 45% predicted at Visit 2.
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.AST, ALT > 1.5 x ULN at Visit 1
- •2.Bilirubin > 1.5 x ULN at Visit 1
- •3.Creatinine clearance <30 mL/min calculated by Cockcroft¿Gault formula at Visit 1.
- •4.Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
- •5.Previous treatment with nintedanib or pirfenidone.
- •6.Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (Visit 1).
- •7.Use of any of the following medications for the treatment of ILD: azathioprine (AZA), cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS) >20mg/day and the combination of OCS+AZA+NAC within 4 weeks of Visit 2, cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of Visit 2.
- •8.Diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 Guidelines.
- •9.Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
- •a.Previous clinical or echocardiographic evidence of significant right heart failure
- •b.History of right heart catheterization showing a cardiac index = 2 l/min/m²
- •c.PAH requiring parenteral therapy with epoprostenol/treprostinil
- •10.Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1).
- •11.In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- •12.Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
- •13.Cardiovascular diseases, any of the following:
- •a.Severe hypertension, uncontrolled under treatment (=160/100 mmHg), within 6 month of Visit 1
- •b.Myocardial infarction within 6 months of Visit 1
- •c.Unstable cardiac angina within 6 months of Visit 1
- •14.Bleeding risk, any of the following:
- •a.Known genetic predisposition to bleeding.
- •b.Patients who require
- •i.Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)
- •ii.High dose antiplatelet therapy.
- •c.History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1.
- •d.Any of the following within 3 months of Visit 1:
- •i.Haemoptysis or haematuria
- •ii.Active gastro-intestinal (GI) bleeding or GI ¿ ulcers
- •iii.Major injury or surgery (Investigators judgment).
- •e.Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN at Visit 1.
- •15.History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
- •16.Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
- •17.Patients with peanut allergy.
- •18.Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
- •19.Life expectancy for disease other than ILD < 2.5 years (Investigator assessment).
- •20.Planned major surgical procedures.
- •21.Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •22.Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information
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